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FDA 510(k)

MAMMOGRAPHY SYSTEM AND CASSETTE

K-Number: K790273 · 1979-03-21

ApplicantAgfa-Gevaert, Inc.
Decision Date1979-03-21
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOGRAPHY SYSTEM AND CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Agfa-Gevaert, Inc.. It received FDA 510(k) clearance on 1979-03-21 under 510(k) number K790273. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAMMOGRAPHY SYSTEM AND CASSETTE?

MAMMOGRAPHY SYSTEM AND CASSETTE is a medical device that received FDA 510(k) clearance on 1979-03-21. The listed applicant is Agfa-Gevaert, Inc.. The 510(k) number is K790273.

When did MAMMOGRAPHY SYSTEM AND CASSETTE receive FDA 510(k) clearance?

MAMMOGRAPHY SYSTEM AND CASSETTE received FDA 510(k) clearance on 1979-03-21, under 510(k) number K790273.

Who is the listed applicant for MAMMOGRAPHY SYSTEM AND CASSETTE?

The FDA 510(k) record lists Agfa-Gevaert, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAMMOGRAPHY SYSTEM AND CASSETTE?

The FDA product code for MAMMOGRAPHY SYSTEM AND CASSETTE is IZH.

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Other records listing Agfa-Gevaert, Inc. 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.

K882096SCOPIX VIDEO IMAGERK832603CURIX CAPACITY FILM CENTER

Related Devices (Code: IZH)

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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