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FDA 510(k)

PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000

K-Number: K984092 · 1999-02-05

ApplicantTrex Medical Corp.
Decision Date1999-02-05
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Trex Medical Corp.. It received FDA 510(k) clearance on 1999-02-05 under 510(k) number K984092. 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 PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000?

PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 is a medical device that received FDA 510(k) clearance on 1999-02-05. The listed applicant is Trex Medical Corp.. The 510(k) number is K984092.

When did PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 receive FDA 510(k) clearance?

PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 received FDA 510(k) clearance on 1999-02-05, under 510(k) number K984092.

Who is the listed applicant for PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000?

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

What is the FDA product code for PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000?

The FDA product code for PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 is IZH.

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Other records listing Trex Medical 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.

K992229MXU-125 OR TMX-125K984091CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000K984414XRE COLLIMATOR WITH SPECTRAL FILTERK982427TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-CK982120DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)

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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