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FDA 510(k)

DICOMPACS, MODEL 5

K-Number: K070618 · 2007-04-25

ApplicantOehm Und Rehbein GmbH
Decision Date2007-04-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DICOMPACS, MODEL 5 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 2007-04-25 under 510(k) number K070618. 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?

DICOMPACS, MODEL 5 is a medical device that received FDA 510(k) clearance on 2007-04-25. The listed applicant is Oehm Und Rehbein GmbH. The 510(k) number is K070618.

When did DICOMPACS, MODEL 5 receive FDA 510(k) clearance?

DICOMPACS, MODEL 5 received FDA 510(k) clearance on 2007-04-25, under 510(k) number K070618.

Who is the listed applicant for DICOMPACS, MODEL 5?

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?

The FDA product code for DICOMPACS, MODEL 5 is LLZ.

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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 PANELK091364DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4

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

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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