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FDA 510(k)

RADIOGRAPHIC INTENSIFYING SCREEN

K-Number: K901014 · 1990-04-02

ApplicantInfab Corp.
Decision Date1990-04-02
Product CodeEAM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIOGRAPHIC INTENSIFYING SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Infab Corp.. It received FDA 510(k) clearance on 1990-04-02 under 510(k) number K901014. 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 RADIOGRAPHIC INTENSIFYING SCREEN?

RADIOGRAPHIC INTENSIFYING SCREEN is a medical device that received FDA 510(k) clearance on 1990-04-02. The listed applicant is Infab Corp.. The 510(k) number is K901014.

When did RADIOGRAPHIC INTENSIFYING SCREEN receive FDA 510(k) clearance?

RADIOGRAPHIC INTENSIFYING SCREEN received FDA 510(k) clearance on 1990-04-02, under 510(k) number K901014.

Who is the listed applicant for RADIOGRAPHIC INTENSIFYING SCREEN?

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

What is the FDA product code for RADIOGRAPHIC INTENSIFYING SCREEN?

The FDA product code for RADIOGRAPHIC 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 Infab 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.

K900970RADIATION PROTECTION GLASSESK900972RADIATION PROTECTION GLOVESK901012RADIOGRAPHIC GRIDK901013RADIOGRAPHIC FILM CASSETTEK896289RADIATION PROTECTION APRON

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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