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FDA 510(k)

MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM

K-Number: K914328 · 1991-12-02

Decision Date1991-12-02
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 1991-12-02 under 510(k) number K914328. 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 MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM?

MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1991-12-02. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K914328.

When did MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM receive FDA 510(k) clearance?

MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM received FDA 510(k) clearance on 1991-12-02, under 510(k) number K914328.

Who is the listed applicant for MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM?

The FDA product code for MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM is IZH.

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.

Other records listing Siemens Medical Solutions USA, 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.

View all 732 devices →

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.

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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