FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)
K Number: K982120
·
Decision Sep 10, 1998
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
6
Review Days
86
Basic Information
- Device Name
- DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)
- K Number
- K982120
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- TREX MEDICAL CORP.
- Date Received
- June 16, 1998
- Decision Date
- September 10, 1998
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by TREX MEDICAL CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K992229 | MXU-125 OR TMX-125 | Aug 6, 1999 | Substantially Equivalent |
| K984091 | CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 | Feb 5, 1999 | Substantially Equivalent |
| K984092 | PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 | Feb 5, 1999 | Substantially Equivalent |
| K984414 | XRE COLLIMATOR WITH SPECTRAL FILTER | Dec 30, 1998 | Substantially Equivalent |
| K982427 | TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C | Sep 23, 1998 | Substantially Equivalent |