- [Home](/) › - [FDAPulse](/v/fdapulse) › - [Hubs](/hub/fdapulse) › - Radiology devices: recent FDA 510(k) clearances # Radiology devices: recent FDA 510(k) clearances **56 radiology devices: recent FDA 510(k) clearances are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Fujifilm Corporation with 3. Data last updated 2026-11-03; each record links to its official source and a full report.** Data as of 2026-11-03 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA Copy citation Download all 56 radiology devices: recent FDA 510(k) clearances (CSV) — $4.99 → Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe [Free sample: 3 records (CSV)](/v1/verticals/fdapulse/records.csv?panel=Radiology&record_type=clearance) 56 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Fujifilm Corporation (3). Each record links to a full report and the official source. Last updated 2026-11-03. Source: U.S. FDA openFDA. **Search, filter and export FDAPulse records** [Run instant live search with these filters](/v/fdapulse?panel=Radiology&record_type=clearance&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/fdapulse/records.csv?panel=Radiology&record_type=clearance) Unlock the full CSV for these filters — $4.99 → ✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days ## Get new FDAPulse records by email (free, weekly) We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email. Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe. [See this week's digest](/digest/fdapulse) Records 56 Most frequent - Fujifilm Corporation (3) - Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2) - Cascination AG (2) - Samsung Medison Co., Ltd. (2) - Avicenna.Ai (2) ## How do I get new radiology devices: recent FDA 510(k) clearances by email? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/fdapulse?panel=Radiology&record_type=clearance) [Watch this exact filter](/v/fdapulse?panel=Radiology&record_type=clearance#more-ways) [See alert plans](/v/fdapulse#pricing) ## What are the top radiology devices: recent FDA 510(k) clearances right now? | Record | Specialty | Type | Date | |---|---|---|---| | VenusCT (K260510): 510(k) cleared for Linatech, LLC | Radiology | 510(k) | 2026-10-19 | | AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd. | Radiology | 510(k) | 2026-10-16 | | Vista AI Scan (K260092): 510(k) cleared for Vista AI, Inc. | Radiology | 510(k) | 2026-10-07 | | syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc. | Radiology | 510(k) | 2026-09-25 | | Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc. | Radiology | 510(k) | 2026-09-24 | | OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd. | Radiology | 510(k) | 2026-09-15 | | BoneVue (K254072): 510(k) cleared for Curvebeam AI / Curvebeam, LLC | Radiology | 510(k) | 2026-09-11 | | BlineSlide (K261679): 510(k) cleared for Deep Breathe, Inc. | Radiology | 510(k) | 2026-10-23 | | PV-iCurve Pro (K261531): 510(k) cleared for Perception Vision Medical Technology Co., Ltd. | Radiology | 510(k) | 2026-10-21 | | Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd. | Radiology | 510(k) | 2026-10-16 | | Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa | Radiology | 510(k) | 2026-10-16 | | Single-Use EBUS Balloon (K261616): 510(k) cleared for Micro-Tech (Nanjing) Co., Ltd. | Radiology | 510(k) | 2026-10-15 | | QGuideCT (1.0) (K260523): 510(k) cleared for Medis Medical Imaging Systems BV | Radiology | 510(k) | 2026-10-05 | | Lung Guidance (K261042): 510(k) cleared for GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | Radiology | 510(k) | 2026-10-02 | | CAS-One IR (K261225): 510(k) cleared for Cascination AG | Radiology | 510(k) | 2026-09-29 | | MD-6000S Bladder Scanner (K260313): 510(k) cleared for MEDA Co., Ltd. | Included in the full CSV with every column 🔒 Unlock all 56 records → | | VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions | Included in the full CSV with every column 🔒 Unlock all 56 records → | | BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125): 510(k) cleared for Samsung HME America, Inc., dba NeuroLogica Corp. | Included in the full CSV with every column 🔒 Unlock all 56 records → | Browse 35 more matching record reports - [MD-6000S Bladder Scanner (K260313): 510(k) cleared for MEDA Co., Ltd.](/report/fdapulse/md-6000s-bladder-scanner-k260313-cn--k260313) - [VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions](/report/fdapulse/virtue-qa-k260597-tn--k260597) - [BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125): 510(k) cleared for Samsung HME America, Inc., dba NeuroLogica Corp.](/report/fdapulse/bodytom-64-nl4100-omnitom-elite-nl5000-k261125-ma--k261125) - [Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden](/report/fdapulse/eden-pacs-k261788-de--k261788) - [OTOPLAN (K262080): 510(k) cleared for Cascination AG](/report/fdapulse/otoplan-k262080-ch--k262080) - [SCENARIA View Phase 6.0 (K261229): 510(k) cleared for Fujifilm Corporation](/report/fdapulse/scenaria-view-phase-6-0-k261229-jp--k261229) - [APERTO Lucent MRI System (K261283): 510(k) cleared for Fujifilm Corporation](/report/fdapulse/aperto-lucent-mri-system-k261283-jp--k261283) - [a2z-Abdo-Triage (K260906): 510(k) cleared for A2z Radiology Ai, Inc.](/report/fdapulse/a2z-abdo-triage-k260906-ma--k260906) - [V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Dia](/report/fdapulse/v10-diagnostic-ultrasound-system-cv10-diagnostic-ultrasound-kr--k263150) - [InkSpace Imaging Small Body Array (SBA12PH15x) (K262813): 510(k) cleared for Inkspace Imaging, Inc.](/report/fdapulse/inkspace-imaging-small-body-array-sba12ph15x-k262813-ca--k262813) - [Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) (K262412): 510(k) cleared for Barco NV](/report/fdapulse/coronis-fusion-4mp-mdcc-4630-coronis-fusion-6mp-mdcc-6630-be--k262412) - [Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (K263033): 510(k) cleared for Fussen Technology Co., Ltd.](/report/fdapulse/dental-computed-tomography-x-ray-system-rubik-xsmart-rubik-cn--k263033) - [Syngo Carbon Space (VA4) (K263048): 510(k) cleared for Siemens Healthineers AG](/report/fdapulse/syngo-carbon-space-va4-k263048-de--k263048) - [EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound](/report/fdapulse/evo-x30-diagnostic-ultrasound-system-evo-x20-diagnostic-kr--k263182) - [CINA-Aneurysm (K262062): 510(k) cleared for Avicenna.Ai](/report/fdapulse/cina-aneurysm-k262062-fr--k262062) - [Accuro XV (K262093): 510(k) cleared for Rivanna Medical, Inc.](/report/fdapulse/accuro-xv-k262093-va--k262093) - [CINA-Aneurysm+ (K262147): 510(k) cleared for Avicenna.Ai](/report/fdapulse/cina-aneurysm-k262147-fr--k262147) - [Rapid ICH (v4.0) (K262301): 510(k) cleared for Ischemaview, Inc.](/report/fdapulse/rapid-ich-v4-0-k262301-co--k262301) - [ECHELON Synergy (K262902): 510(k) cleared for Fujifilm Corporation](/report/fdapulse/echelon-synergy-k262902-jp--k262902) - [Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W](/report/fdapulse/diagnostic-ultrasound-system-resona-i10w-diagnostic-cn--k261617) - [NeuroDR (K262134): 510(k) cleared for Deep Reasoning Ai, Inc.](/report/fdapulse/neurodr-k262134-fl--k262134) - [Ligence Heart (K261733): 510(k) cleared for UAB Ligence](/report/fdapulse/ligence-heart-k261733-lt--k261733) - [RT Elements (4.6) (K261655): 510(k) cleared for Brainlab SE](/report/fdapulse/rt-elements-4-6-k261655-de--k261655) - [Medical Monitor (32MD08WC) (K262985): 510(k) cleared for Lg Electronics.Inc](/report/fdapulse/medical-monitor-32md08wc-k262985-kr--k262985) - [Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (K261933): 510(k) cleared for GE Medical Systems Ultrasound and Primary care Diagnostics, LLC](/report/fdapulse/voluson-expert-18-voluson-expert-20-voluson-expert-22-wi--k261933) - [REMEX-T(K)100C (K261943): 510(k) cleared for Remedi, Inc.](/report/fdapulse/remex-t-k-100c-k261943-kr--k261943) - [SwiftSight-BodyComposition (K261612): 510(k) cleared for Airs Medical, Inc.](/report/fdapulse/swiftsight-bodycomposition-k261612-kr--k261612) - [EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548): 510(k) cleared for Philips Ultrasound, LLC](/report/fdapulse/epiq-inspira-series-diagnostic-ultrasound-system-affiniti-wa--k262548) - [Syneris PACS v.1.0.1.0 (K261874): 510(k) cleared for Syneris](/report/fdapulse/syneris-pacs-v-1-0-1-0-k261874-ca--k261874) - [BoneXpert (K262390): 510(k) cleared for Visiana](/report/fdapulse/bonexpert-k262390-dk--k262390) - [HipStudio Analysis (K262442): 510(k) cleared for Replasia BV](/report/fdapulse/hipstudio-analysis-k262442-be--k262442) - [Rapid Platform (R6.7) (K261368): 510(k) cleared for Ischemaview, Inc.](/report/fdapulse/rapid-platform-r6-7-k261368-co--k261368) - [Elucid PlaqueIQ (K261855): 510(k) cleared for Elucid Bioimaging, Inc.](/report/fdapulse/elucid-plaqueiq-k261855-ma--k261855) - [AerFrame™ Alignment Laser Box (LBV2) (K261865): 510(k) cleared for Stabilix, LLC](/report/fdapulse/aerframe-alignment-laser-box-lbv2-k261865-tx--k261865) - [EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623): 510(k) cleared for GE Medical Systems Ultrasound and Primary Care Diagnostics](/report/fdapulse/echopac-software-only-echopac-plug-in-v211-k261623-wi--k261623) More records in this hub: [page 2](/hub/fdapulse/specialty_type/radiology--510k-clearances/page/2) [Browse all FDAPulse record reports](/hub/fdapulse/records) ## Which related categories and locations should I check? ### Browse by record type [510(k) clearances (414)](/hub/fdapulse/type/510k-clearances) [Class II device recalls (320)](/hub/fdapulse/type/class-ii-recalls) [Class I device recalls (19)](/hub/fdapulse/type/class-i-recalls) [Class III device recalls (11)](/hub/fdapulse/type/class-iii-recalls) ### Browse by specialty [Radiology (56)](/hub/fdapulse/specialty/radiology) [Orthopedic (53)](/hub/fdapulse/specialty/orthopedic) [Cardiovascular (52)](/hub/fdapulse/specialty/cardiovascular) [General & Plastic Surgery (44)](/hub/fdapulse/specialty/general-plastic-surgery) [Dental (32)](/hub/fdapulse/specialty/dental) [Gastroenterology & Urology (27)](/hub/fdapulse/specialty/gastroenterology-urology) [Neurology (23)](/hub/fdapulse/specialty/neurology) [Microbiology (21)](/hub/fdapulse/specialty/microbiology) [Clinical Chemistry (15)](/hub/fdapulse/specialty/clinical-chemistry) [General Hospital (14)](/hub/fdapulse/specialty/general-hospital) [Anesthesiology (12)](/hub/fdapulse/specialty/anesthesiology) [Obstetrics & Gynecology (9)](/hub/fdapulse/specialty/obstetrics-gynecology) [Ophthalmic (7)](/hub/fdapulse/specialty/ophthalmic) ### Browse by record type by specialty [Orthopedic devices: recent FDA 510(k) clearances (53)](/hub/fdapulse/specialty_type/orthopedic--510k-clearances) [Cardiovascular devices: recent FDA 510(k) clearances (52)](/hub/fdapulse/specialty_type/cardiovascular--510k-clearances) [General & Plastic Surgery devices: recent FDA 510(k) clearances (44)](/hub/fdapulse/specialty_type/general-plastic-surgery--510k-clearances) [Dental devices: recent FDA 510(k) clearances (32)](/hub/fdapulse/specialty_type/dental--510k-clearances) [Gastroenterology & Urology devices: recent FDA 510(k) clearances (27)](/hub/fdapulse/specialty_type/gastroenterology-urology--510k-clearances) [Neurology devices: recent FDA 510(k) clearances (23)](/hub/fdapulse/specialty_type/neurology--510k-clearances) [Microbiology devices: recent FDA 510(k) clearances (21)](/hub/fdapulse/specialty_type/microbiology--510k-clearances) [Clinical Chemistry devices: recent FDA 510(k) clearances (15)](/hub/fdapulse/specialty_type/clinical-chemistry--510k-clearances) [General Hospital devices: recent FDA 510(k) clearances (14)](/hub/fdapulse/specialty_type/general-hospital--510k-clearances) [Anesthesiology devices: recent FDA 510(k) clearances (12)](/hub/fdapulse/specialty_type/anesthesiology--510k-clearances) [Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9)](/hub/fdapulse/specialty_type/obstetrics-gynecology--510k-clearances) [Ophthalmic devices: recent FDA 510(k) clearances (7)](/hub/fdapulse/specialty_type/ophthalmic--510k-clearances) ## Frequently asked questions ### How many radiology devices: recent FDA 510(k) clearances are listed? 56 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23. ### Can I get alerts for Radiology devices: recent FDA 510(k) clearances? Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page. Source: U.S. FDA openFDA. Informational only. [RSS feed of new records](/feed/fdapulse.xml) ## Often used together - [NPIPulse](/v/npipulse) - [EPAPulse](/v/epapulse) - [Municipal Public Works Prime Contract Operating Permit Renewal Pulse](/v/pubworksregrenewpulse) - [TrialRecruitmentPageAudit](/trialrecruitmentpageaudit) - [SubdomainShadowPulse](/subdomainshadowpulse) - [MigrationSignalRadar](/migrationsignalradar) Or get the [Healthcare Vendor Bundle](/v/fdapulse#more-ways) for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.