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

FDA 510(k)

Avatar Medical Software V1

K-Number: K222035 · 2023-05-24

ApplicantAvatar Medical
Decision Date2023-05-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Avatar Medical Software V1 is the device name listed in this FDA 510(k) record. The listed applicant is Avatar Medical. It received FDA 510(k) clearance on 2023-05-24 under 510(k) number K222035. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Avatar Medical Software V1?

Avatar Medical Software V1 is a medical device that received FDA 510(k) clearance on 2023-05-24. The listed applicant is Avatar Medical. The 510(k) number is K222035.

When did Avatar Medical Software V1 receive FDA 510(k) clearance?

Avatar Medical Software V1 received FDA 510(k) clearance on 2023-05-24, under 510(k) number K222035.

Who is the listed applicant for Avatar Medical Software V1?

The FDA 510(k) record lists Avatar Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avatar Medical Software V1?

The FDA product code for Avatar Medical Software V1 is LLZ.

Other records listing Avatar Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253950Avatar Medical VisionK252665brAIn™ Shoulder PositioningK243292brAIn™ Shoulder Positioning

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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.

↑