Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KYOKKO UM SERIES INTENSIFYING SCREEN

K-Number: K942399 · 1994-06-10

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date1994-06-10
Product CodeEAM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KYOKKO UM SERIES INTENSIFYING SCREEN 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 1994-06-10 under 510(k) number K942399. 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 KYOKKO UM SERIES INTENSIFYING SCREEN?

KYOKKO UM SERIES INTENSIFYING SCREEN is a medical device that received FDA 510(k) clearance on 1994-06-10. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K942399.

When did KYOKKO UM SERIES INTENSIFYING SCREEN receive FDA 510(k) clearance?

KYOKKO UM SERIES INTENSIFYING SCREEN received FDA 510(k) clearance on 1994-06-10, under 510(k) number K942399.

Who is the listed applicant for KYOKKO UM SERIES INTENSIFYING SCREEN?

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 KYOKKO UM SERIES INTENSIFYING SCREEN?

The FDA product code for KYOKKO UM SERIES INTENSIFYING SCREEN is EAM.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

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

View all 66 devices →

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.

↑