Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Vista OS, Vista AI Scan, RTHawk

K-Number: K251029 · 2025-08-21

ApplicantVista AI, Inc.
Decision Date2025-08-21
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vista OS, Vista AI Scan, RTHawk is a medical device manufactured by Vista AI, Inc.. It received FDA 510(k) clearance on 2025-08-21 under approval number K251029. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vista OS, Vista AI Scan, RTHawk?

Vista OS, Vista AI Scan, RTHawk is a medical device that received FDA 510(k) clearance on 2025-08-21. It is manufactured by Vista AI, Inc.. The 510(k) number is K251029.

When was Vista OS, Vista AI Scan, RTHawk approved by the FDA?

Vista OS, Vista AI Scan, RTHawk received FDA 510(k) clearance on 2025-08-21, under approval number K251029.

What company makes Vista OS, Vista AI Scan, RTHawk?

Vista OS, Vista AI Scan, RTHawk is manufactured by Vista AI, Inc..

What is the FDA product code for Vista OS, Vista AI Scan, RTHawk?

The FDA product code for Vista OS, Vista AI Scan, RTHawk is LNH.

Related Devices (Code: LNH)

K162940MultiBand SENSEPhilips Medical Systems Nederland B.V. K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc. K162403HyperBandGe Medical Systems, LLC K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc. K161973G-scan Brio, S-scanEsaote, S.p.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑