Class Class II
Vista OS, Vista AI Scan, RTHawk (K251029)
Description
Vista OS, Vista AI Scan, RTHawk by Vista AI, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251029
Clearance Date2025-08-21
Clearance TypeTraditional
Product CodeLNH
Regulation Number892.1000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251029
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Vista OS, Vista AI Scan, RTHawk (K251029) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212233 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2021 |
Trace the full predicate network for K251029
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.