FDA 510(k) clearances and recalls: Radiology devices
56 FDA 510(k) clearances and recalls: Radiology devices 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 · Compiled by Zalwin from U.S. FDA openFDA
Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe
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.
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- Fujifilm Corporation (3)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2)
- Cascination AG (2)
- Samsung Medison Co., Ltd. (2)
- Avicenna.Ai (2)
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What are the top FDA 510(k) clearances and recalls: Radiology devices right now?
Browse 35 more matching record reports
- MD-6000S Bladder Scanner (K260313): 510(k) cleared for MEDA Co., Ltd.
- VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions
- BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125): 510(k) cleared for Samsung HME America, Inc., dba NeuroLogica Corp.
- Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden
- OTOPLAN (K262080): 510(k) cleared for Cascination AG
- SCENARIA View Phase 6.0 (K261229): 510(k) cleared for Fujifilm Corporation
- APERTO Lucent MRI System (K261283): 510(k) cleared for Fujifilm Corporation
- a2z-Abdo-Triage (K260906): 510(k) cleared for A2z Radiology Ai, Inc.
- 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
- InkSpace Imaging Small Body Array (SBA12PH15x) (K262813): 510(k) cleared for Inkspace Imaging, Inc.
- Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) (K262412): 510(k) cleared for Barco NV
- 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.
- Syngo Carbon Space (VA4) (K263048): 510(k) cleared for Siemens Healthineers AG
- 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
- CINA-Aneurysm (K262062): 510(k) cleared for Avicenna.Ai
- Accuro XV (K262093): 510(k) cleared for Rivanna Medical, Inc.
- CINA-Aneurysm+ (K262147): 510(k) cleared for Avicenna.Ai
- Rapid ICH (v4.0) (K262301): 510(k) cleared for Ischemaview, Inc.
- ECHELON Synergy (K262902): 510(k) cleared for Fujifilm Corporation
- 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
- NeuroDR (K262134): 510(k) cleared for Deep Reasoning Ai, Inc.
- Ligence Heart (K261733): 510(k) cleared for UAB Ligence
- RT Elements (4.6) (K261655): 510(k) cleared for Brainlab SE
- Medical Monitor (32MD08WC) (K262985): 510(k) cleared for Lg Electronics.Inc
- Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (K261933): 510(k) cleared for GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
- REMEX-T(K)100C (K261943): 510(k) cleared for Remedi, Inc.
- SwiftSight-BodyComposition (K261612): 510(k) cleared for Airs Medical, Inc.
- EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548): 510(k) cleared for Philips Ultrasound, LLC
- Syneris PACS v.1.0.1.0 (K261874): 510(k) cleared for Syneris
- BoneXpert (K262390): 510(k) cleared for Visiana
- HipStudio Analysis (K262442): 510(k) cleared for Replasia BV
- Rapid Platform (R6.7) (K261368): 510(k) cleared for Ischemaview, Inc.
- Elucid PlaqueIQ (K261855): 510(k) cleared for Elucid Bioimaging, Inc.
- AerFrame Alignment Laser Box (LBV2) (K261865): 510(k) cleared for Stabilix, LLC
- EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623): 510(k) cleared for GE Medical Systems Ultrasound and Primary Care Diagnostics
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510(k) clearances (414) Class II device recalls (320) Class I device recalls (19) Class III device recalls (11)
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Orthopedic (53) Cardiovascular (52) General & Plastic Surgery (44) Dental (32) Gastroenterology & Urology (27) Neurology (23) Microbiology (21) Clinical Chemistry (15) General Hospital (14) Anesthesiology (12) Obstetrics & Gynecology (9) Ophthalmic (7)
Browse by record type by specialty
Radiology devices: recent FDA 510(k) clearances (56) Orthopedic devices: recent FDA 510(k) clearances (53) Cardiovascular devices: recent FDA 510(k) clearances (52) General & Plastic Surgery devices: recent FDA 510(k) clearances (44) Dental devices: recent FDA 510(k) clearances (32) Gastroenterology & Urology devices: recent FDA 510(k) clearances (27) Neurology devices: recent FDA 510(k) clearances (23) Microbiology devices: recent FDA 510(k) clearances (21) Clinical Chemistry devices: recent FDA 510(k) clearances (15) General Hospital devices: recent FDA 510(k) clearances (14) Anesthesiology devices: recent FDA 510(k) clearances (12) Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9) Ophthalmic devices: recent FDA 510(k) clearances (7)
Frequently asked questions
How many FDA 510(k) clearances and recalls: Radiology devices 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?
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
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