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FDA 510(k)

KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253

K-Number: K040378 · 2004-05-24

ApplicantEastman Kodak Company
Decision Date2004-05-24
Product CodeIXA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 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 2004-05-24 under 510(k) number K040378. The device is classified under product code IXA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253?

KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 is a medical device that received FDA 510(k) clearance on 2004-05-24. The listed applicant is Eastman Kodak Company. The 510(k) number is K040378.

When did KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 receive FDA 510(k) clearance?

KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 received FDA 510(k) clearance on 2004-05-24, under 510(k) number K040378.

Who is the listed applicant for KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253?

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 CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253?

The FDA product code for KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 is IXA.

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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: IXA)

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.

K081557PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDERJddb Manufacturing, Inc.K053173DS CASSETTEKonica Minolta Medical & Graphic, Inc.K023020AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTEAgfa Corp.K021903KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USEEastman Kodak CompanyK013686KODAK DIRECTVIEW TABLETOP CASSETTEEastman Kodak CompanyK013229LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTEFerrania USA, 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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