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FDA 510(k)

DrAid for Radiology v1

K-Number: K221241 · 2022-09-01

Decision Date2022-09-01
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DrAid for Radiology v1 is the device name listed in this FDA 510(k) record. The listed applicant is Vinbrain Joint Stock Company. It received FDA 510(k) clearance on 2022-09-01 under 510(k) number K221241. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DrAid for Radiology v1?

DrAid for Radiology v1 is a medical device that received FDA 510(k) clearance on 2022-09-01. The listed applicant is Vinbrain Joint Stock Company. The 510(k) number is K221241.

When did DrAid for Radiology v1 receive FDA 510(k) clearance?

DrAid for Radiology v1 received FDA 510(k) clearance on 2022-09-01, under 510(k) number K221241.

Who is the listed applicant for DrAid for Radiology v1?

The FDA 510(k) record lists Vinbrain Joint Stock Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DrAid for Radiology v1?

The FDA product code for DrAid for Radiology v1 is QFM.

Other records listing Vinbrain Joint Stock Company 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.

Related Devices (Code: QFM)

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.

Official Source

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