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FDA 510(k)

ProstatID

K-Number: K212783 · 2022-07-08

ApplicantScanmed, LLC
Decision Date2022-07-08
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ProstatID is a medical device manufactured by Scanmed, LLC. It received FDA 510(k) clearance on 2022-07-08 under approval number K212783. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProstatID?

ProstatID is a medical device that received FDA 510(k) clearance on 2022-07-08. It is manufactured by Scanmed, LLC. The 510(k) number is K212783.

When was ProstatID approved by the FDA?

ProstatID received FDA 510(k) clearance on 2022-07-08, under approval number K212783.

What company makes ProstatID?

ProstatID is manufactured by Scanmed, LLC.

What is the FDA product code for ProstatID?

The FDA product code for ProstatID is QDQ.

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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.

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