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FDA 510(k)

KODAK INTENSIFYING SCREEN SO-168

K-Number: K813139 · 1981-12-08

ApplicantEastman Kodak Company
Decision Date1981-12-08
Product CodeEAM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KODAK INTENSIFYING SCREEN SO-168 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 1981-12-08 under 510(k) number K813139. The device is classified under product code EAM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODAK INTENSIFYING SCREEN SO-168?

KODAK INTENSIFYING SCREEN SO-168 is a medical device that received FDA 510(k) clearance on 1981-12-08. The listed applicant is Eastman Kodak Company. The 510(k) number is K813139.

When did KODAK INTENSIFYING SCREEN SO-168 receive FDA 510(k) clearance?

KODAK INTENSIFYING SCREEN SO-168 received FDA 510(k) clearance on 1981-12-08, under 510(k) number K813139.

Who is the listed applicant for KODAK INTENSIFYING SCREEN SO-168?

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 INTENSIFYING SCREEN SO-168?

The FDA product code for KODAK INTENSIFYING SCREEN SO-168 is EAM.

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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 PACSK051483KODAK DIRECTVIEW DR SYSTEM DETECTOR

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Related Devices (Code: EAM)

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.

K974423ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAILSterling Diagnostic Imaging, Inc.K963913MD100 & MM150Konica Medical Corp.K954161JPI INTENSIFYING SCREENJpi Healthcare Co, Ltd.K943822FUJI UM MAMMO SERIES INTENSIFY SCREENS:Fujifilm Medical System U.S.A., Inc.K943821KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPECFujifilm Medical System U.S.A., Inc.K943823FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12Fujifilm Medical System U.S.A., 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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