FDA 510(k)

Ziehm Vision RFD

K-Number: K203428 · 2021-03-17

Decision Date2021-03-17

Product CodeJAA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Ziehm Vision RFD is a medical device manufactured by Ziehm Imaging GmbH. It received FDA 510(k) clearance on 2021-03-17 under approval number K203428. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ziehm Vision RFD?

Ziehm Vision RFD is a medical device that received FDA 510(k) clearance on 2021-03-17. It is manufactured by Ziehm Imaging GmbH. The 510(k) number is K203428.

When was Ziehm Vision RFD approved by the FDA?

Ziehm Vision RFD received FDA 510(k) clearance on 2021-03-17, under approval number K203428.

What company makes Ziehm Vision RFD?

Ziehm Vision RFD is manufactured by Ziehm Imaging GmbH.

What is the FDA product code for Ziehm Vision RFD?

The FDA product code for Ziehm Vision RFD is JAA.

Other Devices by Ziehm Imaging GmbH

K161976Ziehm Solo FD K193230Ziehm Vision FD K190497Ziehm 8000 K202360Ziehm Vision RFD 3D K231700Ziehm Vision FD K231669Ziehm Solo FD

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K161019Uroview FDPausch Medical GmbH K160301Platinum dRF Imaging SystemApelem-Dms Group K163210Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH K173395MECALL CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A K180651Uroview FD IIPausch Medical GmbH K180589DR 800 with MUSICA DynamicAgfa Healthcare N.V.

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.