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FDA 510(k)

MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR

K-Number: K931882 · 1993-08-23

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

Device Summary

MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR 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 K931882. 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 MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR?

MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR 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 K931882.

When did MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR receive FDA 510(k) clearance?

MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR received FDA 510(k) clearance on 1993-08-23, under 510(k) number K931882.

Who is the listed applicant for MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR?

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 MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR?

The FDA product code for MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR 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.

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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 6586.036K931883AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033K925569AX-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

View on FDA Database →

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

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