FDA 510(k)

StoneChecker

K-Number: K191530 · 2019-09-26

Decision Date2019-09-26

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

StoneChecker is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Biometrics, LLC. It received FDA 510(k) clearance on 2019-09-26 under 510(k) number K191530. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StoneChecker?

StoneChecker is a medical device that received FDA 510(k) clearance on 2019-09-26. The listed applicant is Imaging Biometrics, LLC. The 510(k) number is K191530.

When did StoneChecker receive FDA 510(k) clearance?

StoneChecker received FDA 510(k) clearance on 2019-09-26, under 510(k) number K191530.

Who is the listed applicant for StoneChecker?

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

What is the FDA product code for StoneChecker?

The FDA product code for StoneChecker is LLZ.

Other records listing Imaging Biometrics, LLC 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.

K201092LSN

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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.