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FDA 510(k)

FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK

K-Number: K921112 · 1993-04-27

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date1993-04-27
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 1993-04-27 under 510(k) number K921112. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK?

FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK is a medical device that received FDA 510(k) clearance on 1993-04-27. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K921112.

When did FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK receive FDA 510(k) clearance?

FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK received FDA 510(k) clearance on 1993-04-27, under 510(k) number K921112.

Who is the listed applicant for FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK?

The FDA 510(k) record lists Fujifilm Medical System U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK?

The FDA product code for FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK is KPR.

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Other records listing Fujifilm Medical System U.S.A., Inc. as applicant

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K163675Processor VP-7000, Light Source BL-7000K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)K132188MAMMOGRAPHY VIEWER SMV658K130542SYNAPSE 3D LUNG AND ABDOMEN ANALYSISK130383SYNAPSE 3D CARDIAC TOOLS

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Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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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