CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000— 510(k) K984091
Substantially EquivalentTrex Medical Corp.
FDA 510(k) clearance K984091 for CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000, Substantially Equivalent on 1999-02-05. Applicant: Trex Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Trex Medical Corp.
- Product code
- Code IZH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1710
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Copiague, NY, US
Recent devices under product code IZH
view allMore clearances from Trex Medical Corp.
view all- K992229 — MXU-125 OR TMX-125
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.