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FDA 510(k)

DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION

K-Number: K950608 · 1995-03-02

ApplicantLorad Corp.
Decision Date1995-03-02
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION is the device name listed in this FDA 510(k) record. The listed applicant is Lorad Corp.. It received FDA 510(k) clearance on 1995-03-02 under 510(k) number K950608. 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 DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION?

DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION is a medical device that received FDA 510(k) clearance on 1995-03-02. The listed applicant is Lorad Corp.. The 510(k) number is K950608.

When did DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION receive FDA 510(k) clearance?

DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION received FDA 510(k) clearance on 1995-03-02, under 510(k) number K950608.

Who is the listed applicant for DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION?

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

What is the FDA product code for DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION?

The FDA product code for DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION is IZH.

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Other records listing Lorad Corp. 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.

K992280LORAD 1-650 (INTERNATIONAL 650)K974460LITE TOUCH ERBIUM LASER TREATMENT SYSTEMK973631LORAD M-III ELITE (M-III E)K952210LORAD STEROLOC IIK945241LORAD M-IV, LORAD M-IVIK945496MAMMOGRAPHIC X-RAY UNIT

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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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