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FDA 510(k)

GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM

K-Number: K953902 · 1997-03-19

ApplicantMedical Marketing Intl., Inc.
Decision Date1997-03-19
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Marketing Intl., Inc.. It received FDA 510(k) clearance on 1997-03-19 under 510(k) number K953902. 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 GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM?

GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is Medical Marketing Intl., Inc.. The 510(k) number is K953902.

When did GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM receive FDA 510(k) clearance?

GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM received FDA 510(k) clearance on 1997-03-19, under 510(k) number K953902.

Who is the listed applicant for GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM?

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

What is the FDA product code for GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM?

The FDA product code for GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM is IZH.

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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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