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FDA 510(k)

KODAK DIRECTVIEW DR SYSTEM DETECTOR

K-Number: K051483 · 2005-06-21

ApplicantEastman Kodak Company
Decision Date2005-06-21
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KODAK DIRECTVIEW DR SYSTEM DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Eastman Kodak Company. It received FDA 510(k) clearance on 2005-06-21 under 510(k) number K051483. 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 KODAK DIRECTVIEW DR SYSTEM DETECTOR?

KODAK DIRECTVIEW DR SYSTEM DETECTOR is a medical device that received FDA 510(k) clearance on 2005-06-21. The listed applicant is Eastman Kodak Company. The 510(k) number is K051483.

When did KODAK DIRECTVIEW DR SYSTEM DETECTOR receive FDA 510(k) clearance?

KODAK DIRECTVIEW DR SYSTEM DETECTOR received FDA 510(k) clearance on 2005-06-21, under 510(k) number K051483.

Who is the listed applicant for KODAK DIRECTVIEW DR SYSTEM DETECTOR?

The FDA 510(k) record lists Eastman Kodak Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KODAK DIRECTVIEW DR SYSTEM DETECTOR?

The FDA product code for KODAK DIRECTVIEW DR SYSTEM DETECTOR is MQB.

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Other records listing Eastman Kodak Company 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.

K060550KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386K060137KODAK ECLIPSE IMAGE PROCESSING SOFTWAREK060079KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEMK060055KODAK PACSK053347KODAK CARESTREAM PACSK051258KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345

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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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