Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Quantib Prostate

K-Number: K221106 · 2022-05-13

ApplicantQuantib B.V.
Decision Date2022-05-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Quantib Prostate is the device name listed in this FDA 510(k) record. The listed applicant is Quantib B.V.. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K221106. 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 Quantib Prostate?

Quantib Prostate is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Quantib B.V.. The 510(k) number is K221106.

When did Quantib Prostate receive FDA 510(k) clearance?

Quantib Prostate received FDA 510(k) clearance on 2022-05-13, under 510(k) number K221106.

Who is the listed applicant for Quantib Prostate?

The FDA 510(k) record lists Quantib B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quantib Prostate?

The FDA product code for Quantib Prostate is LLZ.

Related Clinical Trials

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.

NCT06298305Artificial Intelligence & Prostate CancerCOMPLETED

Other records listing Quantib B.V. 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.

K253682DeepHealth ProstateAIK251527Brain WMHK230772Quantib ProstateK213737Quantib NDK202501Quantib ProstateK200899Quantib AI Node

View all 11 devices →

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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.

↑