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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 the device name listed in this FDA 510(k) record. The listed applicant is Scanmed, LLC. It received FDA 510(k) clearance on 2022-07-08 under 510(k) 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. The listed applicant is Scanmed, LLC. The 510(k) number is K212783.

When did ProstatID receive FDA 510(k) clearance?

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

Who is the listed applicant for ProstatID?

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

What is the FDA product code for ProstatID?

The FDA product code for ProstatID is QDQ.

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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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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