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FDA 510(k)

AVIVA MAMMOGRAPHIC X-RAY SYSTEM

K-Number: K915748 · 1992-02-04

ApplicantElscint, Inc.
Decision Date1992-02-04
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AVIVA MAMMOGRAPHIC X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1992-02-04 under 510(k) number K915748. 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 AVIVA MAMMOGRAPHIC X-RAY SYSTEM?

AVIVA MAMMOGRAPHIC X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1992-02-04. The listed applicant is Elscint, Inc.. The 510(k) number is K915748.

When did AVIVA MAMMOGRAPHIC X-RAY SYSTEM receive FDA 510(k) clearance?

AVIVA MAMMOGRAPHIC X-RAY SYSTEM received FDA 510(k) clearance on 1992-02-04, under 510(k) number K915748.

Who is the listed applicant for AVIVA MAMMOGRAPHIC X-RAY SYSTEM?

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

What is the FDA product code for AVIVA MAMMOGRAPHIC X-RAY SYSTEM?

The FDA product code for AVIVA MAMMOGRAPHIC X-RAY SYSTEM is IZH.

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Other records listing Elscint, 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.

K983313ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORYK982060VOLUMAX CT IMAGING SYSTEMK974344CT SCOPEK980306GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EPK974614GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102K9725922T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)

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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

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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