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FDA 510(k)

DICOMPACS DX-R WITH FLAT PANEL

K-Number: K131211 · 2013-11-05

ApplicantOehm Und Rehbein GmbH
Decision Date2013-11-05
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DICOMPACS DX-R WITH FLAT PANEL 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 2013-11-05 under 510(k) number K131211. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DICOMPACS DX-R WITH FLAT PANEL?

DICOMPACS DX-R WITH FLAT PANEL is a medical device that received FDA 510(k) clearance on 2013-11-05. The listed applicant is Oehm Und Rehbein GmbH. The 510(k) number is K131211.

When did DICOMPACS DX-R WITH FLAT PANEL receive FDA 510(k) clearance?

DICOMPACS DX-R WITH FLAT PANEL received FDA 510(k) clearance on 2013-11-05, under 510(k) number K131211.

Who is the listed applicant for DICOMPACS DX-R WITH FLAT PANEL?

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 DX-R WITH FLAT PANEL?

The FDA product code for DICOMPACS DX-R WITH FLAT PANEL is MQB.

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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 miniK091364DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4K070618DICOMPACS, MODEL 5

Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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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