Vista AI Scan (K260092): 510(k) cleared for Vista AI, Inc.
Vista AI Scan (K260092): 510(k) cleared for Vista AI, Inc. (California): 510(k) cleared for Vista AI, Inc. Its amount of 268 is top-decile (90th percentile of 414 records). Dated 28 days ago, it is in the active follow-up window. Score 61/100. 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: 268 · 90th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260092 |
| Device | Vista AI Scan |
| Applicant | Vista AI, Inc. |
| Specialty / panel | Radiology |
| Product code | LNH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-12 |
| Decision date | 2026-10-07 |
| Review time (days) | 268 |
| Third-party review | No |
| Applicant location | Palo Alto, CA, US |
| amount percentile | 90th of 414 (median 138, 1.9x median) |
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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: 2026-10-07
- Data refreshed: 2026-11-04
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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: Vista AI Scan (K260092): 510(k) cleared for Vista AI, Inc. and 76 California peers
- California FDAPulse records like this one: 76
- Vista AI Scan (K260092): 510(k) cleared for Vista AI, Inc.'s amount: 90th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 268-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 28 days ago.
What is the FDAPulse record for Vista AI Scan (K260092): 510(k) cleared for Vista AI, Inc. in California?
Vista AI Scan (K260092) by Vista AI, Inc. was cleared on 2026-10-07 after 268 days of review.
How does Vista AI Scan (K260092): 510(k) cleared for Vista AI, Inc. compare to other California FDAPulse records?
This is a top-decile record: its amount of 268 is 1.9x the median of 138 across 414 records. It is 28 days old, still within a typical 45-day follow-up window.
Vista AI Scan (K260092) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Vista AI Scan (K260092) | CA | 2026-10-07 |
| VenusCT (K260510) | CA | 2026-10-19 |
| BlineSlide (K261679) | CA | 2026-10-23 |
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