MXU-125 OR TMX-125— 510(k) K992229
Substantially EquivalentTrex Medical Corp.
FDA 510(k) clearance K992229 for MXU-125 OR TMX-125, Substantially Equivalent on 1999-08-06. Applicant: Trex Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Trex Medical Corp.
- Product code
- Code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danbury, CT, US
Recent devices under product code IZL
view allMore clearances from Trex Medical Corp.
view all- K984091 — CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000
- K984092 — PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000
- K984414 — XRE COLLIMATOR WITH SPECTRAL FILTER
- K982427 — TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C
- K982120 — DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)
Adverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.