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FDA 510(k)

AmCAD-UT Detection 2.2

K-Number: K180006 · 2018-08-31

ApplicantAmcad Biomed Corporation
Decision Date2018-08-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AmCAD-UT Detection 2.2 is the device name listed in this FDA 510(k) record. The listed applicant is Amcad Biomed Corporation. It received FDA 510(k) clearance on 2018-08-31 under 510(k) number K180006. 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 AmCAD-UT Detection 2.2?

AmCAD-UT Detection 2.2 is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is Amcad Biomed Corporation. The 510(k) number is K180006.

When did AmCAD-UT Detection 2.2 receive FDA 510(k) clearance?

AmCAD-UT Detection 2.2 received FDA 510(k) clearance on 2018-08-31, under 510(k) number K180006.

Who is the listed applicant for AmCAD-UT Detection 2.2?

The FDA 510(k) record lists Amcad Biomed Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AmCAD-UT Detection 2.2?

The FDA product code for AmCAD-UT Detection 2.2 is LLZ.

Other records listing Amcad Biomed Corporation 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.

K203555AmCAD-UTK180867AmCAD-UOK162574AmCAD-USK170069AmCAD-UV

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

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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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