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FDA 510(k)

WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE

K-Number: K111865 · 2011-09-30

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date2011-09-30
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 2011-09-30 under 510(k) number K111865. 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 WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE?

WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE is a medical device that received FDA 510(k) clearance on 2011-09-30. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K111865.

When did WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE receive FDA 510(k) clearance?

WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE received FDA 510(k) clearance on 2011-09-30, under 510(k) number K111865.

Who is the listed applicant for WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE?

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

What is the FDA product code for WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE?

The FDA product code for WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE is MQB.

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Other records listing Fujifilm Medical System U.S.A., Inc. as applicant

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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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