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FDA 510(k)

DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4

K-Number: K091364 · 2009-12-11

ApplicantOehm Und Rehbein GmbH
Decision Date2009-12-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 is the device name listed in this FDA 510(k) record. The listed applicant is Oehm Und Rehbein GmbH. It received FDA 510(k) clearance on 2009-12-11 under 510(k) number K091364. 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 DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4?

DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 is a medical device that received FDA 510(k) clearance on 2009-12-11. The listed applicant is Oehm Und Rehbein GmbH. The 510(k) number is K091364.

When did DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 receive FDA 510(k) clearance?

DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 received FDA 510(k) clearance on 2009-12-11, under 510(k) number K091364.

Who is the listed applicant for DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4?

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

What is the FDA product code for DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4?

The FDA product code for DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 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.

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Other records listing Oehm Und Rehbein 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.

K182317AMADEO M-DR mini, AMADEO M-AX miniK131211DICOMPACS DX-R WITH FLAT PANELK070618DICOMPACS, MODEL 5

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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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