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FDA 510(k)

MAMMOGRAPH

K-Number: K010792 · 2001-04-03

ApplicantDigitec Medical Service Corp.
Decision Date2001-04-03
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Digitec Medical Service Corp.. It received FDA 510(k) clearance on 2001-04-03 under 510(k) number K010792. 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 MAMMOGRAPH?

MAMMOGRAPH is a medical device that received FDA 510(k) clearance on 2001-04-03. The listed applicant is Digitec Medical Service Corp.. The 510(k) number is K010792.

When did MAMMOGRAPH receive FDA 510(k) clearance?

MAMMOGRAPH received FDA 510(k) clearance on 2001-04-03, under 510(k) number K010792.

Who is the listed applicant for MAMMOGRAPH?

The FDA 510(k) record lists Digitec Medical Service Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAMMOGRAPH?

The FDA product code for MAMMOGRAPH is IZH.

Related Clinical Trials

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Other records listing Digitec Medical Service 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.

K993681DIGITEC TWO STAGE COMPRESSION KIT

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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