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FDA 510(k)

AmCAD-US

K-Number: K162574 · 2017-05-30

ApplicantAmcad Biomed Corporation
Decision Date2017-05-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AmCAD-US is a medical device manufactured by Amcad Biomed Corporation. It received FDA 510(k) clearance on 2017-05-30 under approval number K162574. 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-US?

AmCAD-US is a medical device that received FDA 510(k) clearance on 2017-05-30. It is manufactured by Amcad Biomed Corporation. The 510(k) number is K162574.

When was AmCAD-US approved by the FDA?

AmCAD-US received FDA 510(k) clearance on 2017-05-30, under approval number K162574.

What company makes AmCAD-US?

AmCAD-US is manufactured by Amcad Biomed Corporation.

What is the FDA product code for AmCAD-US?

The FDA product code for AmCAD-US is LLZ.

Other Devices by Amcad Biomed Corporation

K170069AmCAD-UV K180867AmCAD-UO K180006AmCAD-UT Detection 2.2 K203555AmCAD-UT

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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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