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FDA 510(k)

UMI X-RAY FILM CASSETTE

K-Number: K971431 · 1997-05-20

ApplicantUmi Intl.
Decision Date1997-05-20
Product CodeIXA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UMI X-RAY FILM CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Umi Intl.. It received FDA 510(k) clearance on 1997-05-20 under 510(k) number K971431. The device is classified under product code IXA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UMI X-RAY FILM CASSETTE?

UMI X-RAY FILM CASSETTE is a medical device that received FDA 510(k) clearance on 1997-05-20. The listed applicant is Umi Intl.. The 510(k) number is K971431.

When did UMI X-RAY FILM CASSETTE receive FDA 510(k) clearance?

UMI X-RAY FILM CASSETTE received FDA 510(k) clearance on 1997-05-20, under 510(k) number K971431.

Who is the listed applicant for UMI X-RAY FILM CASSETTE?

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

What is the FDA product code for UMI X-RAY FILM CASSETTE?

The FDA product code for UMI X-RAY FILM CASSETTE is IXA.

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Related Devices (Code: IXA)

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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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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