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FDA 510(k)

DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM

K-Number: K003473 · 2000-11-28

ApplicantElscintec Systems , Ltd.
Decision Date2000-11-28
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Elscintec Systems , Ltd.. It received FDA 510(k) clearance on 2000-11-28 under 510(k) number K003473. 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 DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM?

DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM is a medical device that received FDA 510(k) clearance on 2000-11-28. The listed applicant is Elscintec Systems , Ltd.. The 510(k) number is K003473.

When did DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM receive FDA 510(k) clearance?

DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM received FDA 510(k) clearance on 2000-11-28, under 510(k) number K003473.

Who is the listed applicant for DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM?

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

What is the FDA product code for DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM?

The FDA product code for DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM is IZH.

Related Clinical Trials

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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.

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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