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)

FUJI COMPUTED RADIOGRAPHY SYSTEMS

K-Number: K944046 · 1995-05-11

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date1995-05-11
Product CodeIXW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJI COMPUTED RADIOGRAPHY SYSTEMS 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 1995-05-11 under 510(k) number K944046. The device is classified under product code IXW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJI COMPUTED RADIOGRAPHY SYSTEMS?

FUJI COMPUTED RADIOGRAPHY SYSTEMS is a medical device that received FDA 510(k) clearance on 1995-05-11. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K944046.

When did FUJI COMPUTED RADIOGRAPHY SYSTEMS receive FDA 510(k) clearance?

FUJI COMPUTED RADIOGRAPHY SYSTEMS received FDA 510(k) clearance on 1995-05-11, under 510(k) number K944046.

Who is the listed applicant for FUJI COMPUTED RADIOGRAPHY SYSTEMS?

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 SYSTEMS?

The FDA product code for FUJI COMPUTED RADIOGRAPHY SYSTEMS is IXW.

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: IXW)

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.

K111167XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINTVelopex International, Inc.K093503INTRAX FILM PROCESSORVelopex International, Inc.K091628OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAXProtec GmbH & Co. KGK024342RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000Daito Co., Ltd.K023801FILM PROCESSOR, MODEL LIFE RAY PRO 1000S.A.I.E.P. S.R.L.K023825FILM PROCESSOR, MODEL LIFE RAY PRO 2500S.A.I.E.P. S.R.L.

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.

↑