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FDA 510(k)

AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033

K-Number: K931883 · 1993-08-23

ApplicantAlphatek Corp.
Decision Date1993-08-23
Product CodeIXW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033 is the device name listed in this FDA 510(k) record. The listed applicant is Alphatek Corp.. It received FDA 510(k) clearance on 1993-08-23 under 510(k) number K931883. 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-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033?

AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033 is a medical device that received FDA 510(k) clearance on 1993-08-23. The listed applicant is Alphatek Corp.. The 510(k) number is K931883.

When did AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033 receive FDA 510(k) clearance?

AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033 received FDA 510(k) clearance on 1993-08-23, under 510(k) number K931883.

Who is the listed applicant for AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033?

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-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033?

The FDA product code for AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033 is IXW.

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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 PROCESSORK925569AX-700LE AUTOMATIC X-RAY FILM PROCESSORK924430AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027

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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