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FDA 510(k)

MXU-125 OR TMX-125

K-Number: K992229 · 1999-08-06

ApplicantTrex Medical Corp.
Decision Date1999-08-06
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MXU-125 OR TMX-125 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 1999-08-06 under 510(k) number K992229. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MXU-125 OR TMX-125?

MXU-125 OR TMX-125 is a medical device that received FDA 510(k) clearance on 1999-08-06. The listed applicant is Trex Medical Corp.. The 510(k) number is K992229.

When did MXU-125 OR TMX-125 receive FDA 510(k) clearance?

MXU-125 OR TMX-125 received FDA 510(k) clearance on 1999-08-06, under 510(k) number K992229.

Who is the listed applicant for MXU-125 OR TMX-125?

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 MXU-125 OR TMX-125?

The FDA product code for MXU-125 OR TMX-125 is IZL.

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.

K984091CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000K984092PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-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: IZL)

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.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

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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