BoneVue (K254072): 510(k) cleared for Curvebeam AI / Curvebeam, LLC
BoneVue (K254072): 510(k) cleared for Curvebeam AI / Curvebeam, LLC (Pennsylvania): 510(k) cleared for Curvebeam AI / Curvebeam, LLC. Its amount of 267 is above the median of 138 (88th percentile). Dated 55 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-04, 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: 267 · 88th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 18 related PA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254072 |
| Device | BoneVue |
| Applicant | Curvebeam AI / Curvebeam, LLC |
| Specialty / panel | Radiology |
| Product code | KGI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-18 |
| Decision date | 2026-09-11 |
| Review time (days) | 267 |
| Third-party review | No |
| Applicant location | Hatfield, PA, US |
| amount percentile | 88th of 414 (median 138, 1.9x median) |
| Peer records CSV (19 PA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-09-11
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: BoneVue (K254072): 510(k) cleared for Curvebeam AI / Curvebeam, LLC and 19 Pennsylvania peers
- Pennsylvania FDAPulse records like this one: 19
- BoneVue (K254072): 510(k) cleared for Curvebeam AI / Curvebeam, LLC's amount: 88th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $3,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 267-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for BoneVue (K254072): 510(k) cleared for Curvebeam AI / Curvebeam, LLC in Pennsylvania?
BoneVue (K254072) by Curvebeam AI / Curvebeam, LLC was cleared on 2026-09-11 after 267 days of review.
How does BoneVue (K254072): 510(k) cleared for Curvebeam AI / Curvebeam, LLC compare to other Pennsylvania FDAPulse records?
Its amount of 267 sits in the upper half (88th percentile) of 414 records; the median is 138. It is 55 days old; check the official source for later updates before acting.
BoneVue (K254072) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| BoneVue (K254072) | PA | 2026-09-11 |
| VenusCT (K260510) | CA | 2026-10-19 |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
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