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FDA 510(k)

FUJI CR IMAGING PLATE

K-Number: K862414 · 1987-02-26

ApplicantParexel Intl. Corp.
Decision Date1987-02-26
Product CodeEAM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJI CR IMAGING PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Parexel Intl. Corp.. It received FDA 510(k) clearance on 1987-02-26 under 510(k) number K862414. 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 FUJI CR IMAGING PLATE?

FUJI CR IMAGING PLATE is a medical device that received FDA 510(k) clearance on 1987-02-26. The listed applicant is Parexel Intl. Corp.. The 510(k) number is K862414.

When did FUJI CR IMAGING PLATE receive FDA 510(k) clearance?

FUJI CR IMAGING PLATE received FDA 510(k) clearance on 1987-02-26, under 510(k) number K862414.

Who is the listed applicant for FUJI CR IMAGING PLATE?

The FDA 510(k) record lists Parexel Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJI CR IMAGING PLATE?

The FDA product code for FUJI CR IMAGING PLATE is EAM.

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Other records listing Parexel Intl. Corp. 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.

K900385ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGEK904901L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUCK904902SMA 26 TRANSDUCERK884800ACTA GENOS ELECTROCARDIOGRAPHK864519PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)K862416FTI 100 MEDICAL THERMAL IMAGER

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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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