BoneXpert (K262390): 510(k) cleared for Visiana
BoneXpert (K262390): 510(k) cleared for Visiana: 510(k) cleared for Visiana. Its amount of 71 is below the median of 138 (19th percentile). Dated 43 days ago, it serves as a historical benchmark. Score 36/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 71 · 19th percentile of 414 FDAPulse records · 0.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 3 related DK FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262390 |
| Device | BoneXpert |
| Applicant | Visiana |
| Specialty / panel | Radiology |
| Product code | QIH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-13 |
| Decision date | 2026-09-22 |
| Review time (days) | 71 |
| Third-party review | No |
| Applicant location | Horsholm, DK |
| amount percentile | 19th of 414 (median 138, 0.5x median) |
| Peer records CSV (4 DK records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch BoneXpert (K262390): 510(k) cleared for Visiana
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Free first: a 10-record sample of DK records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock BoneXpert (K262390): 510(k) cleared for Visiana + all 4 DK records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-22
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (DK first): Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2 · Elos Accurate Hybrid Base (K261327) · Ambu® aScope Gastro; Ambu® aScope Gastro Large (K261400) · SmartIPL_NI System (K241973) · Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: BoneXpert (K262390): 510(k) cleared for Visiana and 4 DK peers
- DK FDAPulse records like this one: 4
- BoneXpert (K262390): 510(k) cleared for Visiana's amount: 19th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every DK peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 71-day review: this device is a strong predicate for similar products.
- Posted 43 days ago.
What is the FDAPulse record for BoneXpert (K262390): 510(k) cleared for Visiana?
BoneXpert (K262390) by Visiana was cleared on 2026-09-22 after 71 days of review.
How does BoneXpert (K262390): 510(k) cleared for Visiana compare to other FDAPulse records?
Its amount of 71 is below the median (19th percentile); smaller records often move faster and face less competition. It is 43 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
BoneXpert (K262390) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| BoneXpert (K262390) | DK | 2026-09-22 |
| VenusCT (K260510) | CA | 2026-10-19 |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
Related records
- VenusCT (K260510): 510(k) cleared for Linatech, LLC
- AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd.
- Vista AI Scan (K260092): 510(k) cleared for Vista AI, Inc.
- syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc.
- Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc.
- OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd.
- BoneVue (K254072): 510(k) cleared for Curvebeam AI / Curvebeam, LLC
- BlineSlide (K261679): 510(k) cleared for Deep Breathe, Inc.
- PV-iCurve Pro (K261531): 510(k) cleared for Perception Vision Medical Technology Co., Ltd.
- Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd.
- 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
- Single-Use EBUS Balloon (K261616): 510(k) cleared for Micro-Tech (Nanjing) Co., Ltd.
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Radiology devices
How to monitor BoneXpert (K262390): 510(k) cleared for Visiana and peer radiology records
Get new FDAPulse records like BoneXpert (K262390): 510(k) cleared for Visiana 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.
Get clearances and recalls like this every day
FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.
✓ 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
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
Often used together
- NPIPulse
- EPAPulse
- Municipal Public Works Prime Contract Operating Permit Renewal Pulse
- TrialRecruitmentPageAudit
- SubdomainShadowPulse
- MigrationSignalRadar
Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.