Vista AI Scan— 510(k) K260092

Name: FDA 510(k) clearance K260092
Creator: U.S. Food and Drug Administration
Published: 2026-10-07

Substantially Equivalent

Vista AI, Inc.

FDA 510(k) clearance K260092 for Vista AI Scan, Substantially Equivalent on 2026-10-07. Applicant: Vista AI, Inc.. Device class: 2.

Summary

Vista AI Scan from Vista AI is filed under LNH, nuclear magnetic resonance imaging systems. The record doesn't say whether it's a scanner, software that runs on one, or both.

Class II, 21 CFR 892.1000. The Radiology panel reviewed it as a Traditional 510(k).

Vista AI filed from Palo Alto, California. Review took 268 days (January 12 to October 7, 2026).

Clearance details

Applicant: Vista AI, Inc.
Product code: Product code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2026-01-12
Decision date: 2026-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.