DrAid for Radiology v1— 510(k) K221241

Name: FDA 510(k) clearance K221241
Creator: U.S. Food and Drug Administration
Published: 2022-09-01

Substantially Equivalent

Vinbrain Joint Stock Company

FDA 510(k) clearance K221241 for DrAid for Radiology v1, Substantially Equivalent on 2022-09-01. Applicant: Vinbrain Joint Stock Company. Device class: 2.

Clearance details

Applicant: Vinbrain Joint Stock Company
Product code: Code QFM
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2022-04-29
Decision date: 2022-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Viet Hung Ward, Long Bien District, VN

Download summary PDF View on FDA.gov ↗

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