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FDA 510(k)

WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR

K-Number: K103596 · 2011-03-29

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2011-03-29
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2011-03-29 under 510(k) number K103596. 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 WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR?

WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR is a medical device that received FDA 510(k) clearance on 2011-03-29. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K103596.

When did WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR receive FDA 510(k) clearance?

WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR received FDA 510(k) clearance on 2011-03-29, under 510(k) number K103596.

Who is the listed applicant for WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR?

The FDA product code for WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR is MQB.

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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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