Avatar Medical Software V1

FDA 510(k) K222035 · Avatar Medical

Substantially Equivalent

510(k) numberK222035

Submission

Device name
Avatar Medical Software V1
Applicant
Avatar Medical
Paris, FR
Received
July 11, 2022
Decision date
May 24, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Avatar Medical Software V1 cleared by the FDA?

Avatar Medical Software V1 (K222035) received a 510(k) decision of Substantially Equivalent on May 24, 2023, 317 days after the submission was received.

What is the product code of K222035?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.