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FDA 510(k)

CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS

K-Number: K981280 · 1998-04-30

ApplicantBayer Corp., Agfa Div.
Decision Date1998-04-30
Product CodeIXW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp., Agfa Div.. It received FDA 510(k) clearance on 1998-04-30 under 510(k) number K981280. 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 CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS?

CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS is a medical device that received FDA 510(k) clearance on 1998-04-30. The listed applicant is Bayer Corp., Agfa Div.. The 510(k) number is K981280.

When did CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS receive FDA 510(k) clearance?

CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS received FDA 510(k) clearance on 1998-04-30, under 510(k) number K981280.

Who is the listed applicant for CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS?

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

What is the FDA product code for CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS?

The FDA product code for CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS 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 Bayer Corp., Agfa Div. 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.

K974597ADC COMPACT (AGFA DIAGNOSTIC CENTER)K964414LR 5200 LASER FILM RECORDER

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

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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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