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FDA 510(k)

GIOTTO HT

K-Number: K973856 · 1997-11-21

ApplicantSitco, Inc.
Decision Date1997-11-21
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GIOTTO HT is the device name listed in this FDA 510(k) record. The listed applicant is Sitco, Inc.. It received FDA 510(k) clearance on 1997-11-21 under 510(k) number K973856. 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 HT?

GIOTTO HT is a medical device that received FDA 510(k) clearance on 1997-11-21. The listed applicant is Sitco, Inc.. The 510(k) number is K973856.

When did GIOTTO HT receive FDA 510(k) clearance?

GIOTTO HT received FDA 510(k) clearance on 1997-11-21, under 510(k) number K973856.

Who is the listed applicant for GIOTTO HT?

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

What is the FDA product code for GIOTTO HT?

The FDA product code for GIOTTO HT is IZH.

Related Clinical Trials

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Other records listing Sitco, 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.

K990192BIOPSY-DIGITK982049BIOPSY MK953255NUQUEST NUCLEAR MEDICINE COMPUTER

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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, Inc.

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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