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FDA 510(k)

MAMMOGRAPHIC X-RAY SYSTEM

K-Number: K913732 · 1992-02-03

ApplicantLorad Medical Systems, Inc.
Decision Date1992-02-03
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOGRAPHIC X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lorad Medical Systems, Inc.. It received FDA 510(k) clearance on 1992-02-03 under 510(k) number K913732. 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 MAMMOGRAPHIC X-RAY SYSTEM?

MAMMOGRAPHIC X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1992-02-03. The listed applicant is Lorad Medical Systems, Inc.. The 510(k) number is K913732.

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

MAMMOGRAPHIC X-RAY SYSTEM received FDA 510(k) clearance on 1992-02-03, under 510(k) number K913732.

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

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

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

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

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Other records listing Lorad Medical Systems, 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.

K921962LORAD DIGITAL SPOT MAMMOGRAPHYK922619DIGITIZER, MODEL # 3-000A-1518K913478RADIOGRAPHIC FILM MARKING SYSTEMK894935S-70 PORTABLE DENTAL X-RAY SYSTEMK894643RT-125 ROUGH TERRAIN MOBILE X-RAY UNITK882875STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY

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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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