FDA 510(k)

CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN

K-Number: K893510 · 1989-06-23

ApplicantE.I. Dupont DE Nemours & Co., Inc.

Decision Date1989-06-23

Product CodeEAM

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K893510. 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 CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN?

CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K893510.

When did CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN receive FDA 510(k) clearance?

CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN received FDA 510(k) clearance on 1989-06-23, under 510(k) number K893510.

Who is the listed applicant for CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN?

The FDA product code for CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN is EAM.

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Other records listing E.I. Dupont DE Nemours & Co., Inc. as applicant

K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY K953724CRONEX RADIATION THERAPY CASSETTE K953725CRONEX RADIATION THERAPY VERIFICATION CASSETTE K951441DUPONT ACA DIGOXIN (DGN A) METHOD K950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE K950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

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Related Devices (Code: EAM)

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.