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FDA 510(k)

BIOPSY DIGIT S BIOPSY SL

K-Number: K113607 · 2012-08-10

ApplicantGiotto USA, LLC
Decision Date2012-08-10
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOPSY DIGIT S BIOPSY SL 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 2012-08-10 under 510(k) number K113607. 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 S BIOPSY SL?

BIOPSY DIGIT S BIOPSY SL is a medical device that received FDA 510(k) clearance on 2012-08-10. The listed applicant is Giotto USA, LLC. The 510(k) number is K113607.

When did BIOPSY DIGIT S BIOPSY SL receive FDA 510(k) clearance?

BIOPSY DIGIT S BIOPSY SL received FDA 510(k) clearance on 2012-08-10, under 510(k) number K113607.

Who is the listed applicant for BIOPSY DIGIT S BIOPSY SL?

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 S BIOPSY SL?

The FDA product code for BIOPSY DIGIT S BIOPSY SL 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.

K111434GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-LK062039BIOPSY DIGIT-AM

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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