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FDA 510(k)

BIOPSY DIGIT-AM

K-Number: K062039 · 2006-09-11

ApplicantGiotto USA, LLC
Decision Date2006-09-11
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOPSY DIGIT-AM is the device name listed in this FDA 510(k) record. The listed applicant is Giotto USA, LLC. It received FDA 510(k) clearance on 2006-09-11 under 510(k) number K062039. 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 BIOPSY DIGIT-AM?

BIOPSY DIGIT-AM is a medical device that received FDA 510(k) clearance on 2006-09-11. The listed applicant is Giotto USA, LLC. The 510(k) number is K062039.

When did BIOPSY DIGIT-AM receive FDA 510(k) clearance?

BIOPSY DIGIT-AM received FDA 510(k) clearance on 2006-09-11, under 510(k) number K062039.

Who is the listed applicant for BIOPSY DIGIT-AM?

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

What is the FDA product code for BIOPSY DIGIT-AM?

The FDA product code for BIOPSY DIGIT-AM is IZH.

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Other records listing Giotto USA, LLC 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.

K113607BIOPSY DIGIT S BIOPSY SLK111434GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L

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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