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)

AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027

K-Number: K924430 · 1992-11-27

ApplicantAlphatek Corp.
Decision Date1992-11-27
Product CodeIXW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027 is the device name listed in this FDA 510(k) record. The listed applicant is Alphatek Corp.. It received FDA 510(k) clearance on 1992-11-27 under 510(k) number K924430. 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 AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027?

AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027 is a medical device that received FDA 510(k) clearance on 1992-11-27. The listed applicant is Alphatek Corp.. The 510(k) number is K924430.

When did AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027 receive FDA 510(k) clearance?

AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027 received FDA 510(k) clearance on 1992-11-27, under 510(k) number K924430.

Who is the listed applicant for AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027?

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

What is the FDA product code for AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027?

The FDA product code for AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027 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 Alphatek 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.

K023613AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036K931882MAMMO-300 AUTOMATIC X-RAY FILM PROCESSORK931883AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033K925569AX-700LE AUTOMATIC X-RAY FILM PROCESSOR

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.

↑