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FDA 510(k)

KODAK INSIGHT TWIN-LOAD INSERT

K-Number: K942909 · 1994-07-29

ApplicantEastman Kodak Company
Decision Date1994-07-29
Product CodeEAM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KODAK INSIGHT TWIN-LOAD INSERT 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 1994-07-29 under 510(k) number K942909. 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 INSIGHT TWIN-LOAD INSERT?

KODAK INSIGHT TWIN-LOAD INSERT is a medical device that received FDA 510(k) clearance on 1994-07-29. The listed applicant is Eastman Kodak Company. The 510(k) number is K942909.

When did KODAK INSIGHT TWIN-LOAD INSERT receive FDA 510(k) clearance?

KODAK INSIGHT TWIN-LOAD INSERT received FDA 510(k) clearance on 1994-07-29, under 510(k) number K942909.

Who is the listed applicant for KODAK INSIGHT TWIN-LOAD INSERT?

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 INSIGHT TWIN-LOAD INSERT?

The FDA product code for KODAK INSIGHT TWIN-LOAD INSERT 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.K943823FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12Fujifilm Medical System U.S.A., Inc.K943821KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPECFujifilm 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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