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FDA 510(k)

KODAK X-OMAT G FILM

K-Number: K792448 · 1980-01-09

ApplicantEastman Kodak Company
Decision Date1980-01-09
Product CodeIWZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KODAK X-OMAT G FILM 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 1980-01-09 under 510(k) number K792448. The device is classified under product code IWZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODAK X-OMAT G FILM?

KODAK X-OMAT G FILM is a medical device that received FDA 510(k) clearance on 1980-01-09. The listed applicant is Eastman Kodak Company. The 510(k) number is K792448.

When did KODAK X-OMAT G FILM receive FDA 510(k) clearance?

KODAK X-OMAT G FILM received FDA 510(k) clearance on 1980-01-09, under 510(k) number K792448.

Who is the listed applicant for KODAK X-OMAT G FILM?

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 X-OMAT G FILM?

The FDA product code for KODAK X-OMAT G FILM is IWZ.

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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: IWZ)

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.

K970154KODAK EKTASIAN HG FILM (EHG-15)Eastman Kodak CompanyK954200VOXGRAMVoxelK9316043M MEDICAL DIAGNOSTIC VIDEOCASSETTE3M Health Care, Ltd.K9316053M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE3M Health Care, Ltd.K920539ORWO X-RAY FILMBurkhart Roentgen Intl., Inc.K884827KODAK DENTAL BARRIER PACEastman Kodak Company

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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