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FDA 510(k)

ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN

K-Number: K933161 · 1993-10-07

ApplicantDupont Medical Products
Decision Date1993-10-07
Product CodeEAM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Dupont Medical Products. It received FDA 510(k) clearance on 1993-10-07 under 510(k) number K933161. 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 ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN?

ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN is a medical device that received FDA 510(k) clearance on 1993-10-07. The listed applicant is Dupont Medical Products. The 510(k) number is K933161.

When did ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN receive FDA 510(k) clearance?

ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN received FDA 510(k) clearance on 1993-10-07, under 510(k) number K933161.

Who is the listed applicant for ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN?

The FDA 510(k) record lists Dupont Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN?

The FDA product code for ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN is EAM.

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Other records listing Dupont Medical Products 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.

K952815DUPONT LIPASE CALIBRATORK950920DUPONT DIMENSION TOTAL PROTEIN METHODK952816LIPASE FLEX REAGENT CARTRIDGEK952412DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROLK945280DUPONT DIMENSION C-REACTIVE PROTEIN METHODK944932PHENOBARBITAL FLEX REAGENT CARTRIDGE

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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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