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FDA 510(k)

ZIEHM VISION RFD

K-Number: K132904 · 2013-12-05

ApplicantZiehm Imaging GmbH
Decision Date2013-12-05
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZIEHM VISION RFD is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm Imaging GmbH. It received FDA 510(k) clearance on 2013-12-05 under 510(k) number K132904. 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 2013-12-05. The listed applicant is Ziehm Imaging GmbH. The 510(k) number is K132904.

When did ZIEHM VISION RFD receive FDA 510(k) clearance?

ZIEHM VISION RFD received FDA 510(k) clearance on 2013-12-05, under 510(k) number K132904.

Who is the listed applicant for ZIEHM VISION RFD?

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

What is the FDA product code for ZIEHM VISION RFD?

The FDA product code for ZIEHM VISION RFD is JAA.

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Other records listing Ziehm Imaging GmbH 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.

K243646Ziehm Solo FDK243735Ziehm Vision FDK243303Ziehm Vision RFD 3DK243328Ziehm Vision RFDK240099Ziehm Vision RFDK240020Ziehm Vision FD

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Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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