FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUPERIX 120
K Number: K811197
·
Decision Jun 9, 1981
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
41
Applicant Total
18
Review Days
40
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SUPERIX 120
- K Number
- K811197
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1740
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Tecnomed, Inc.
- Date Received
- April 30, 1981
- Decision Date
- June 9, 1981
- Product Code
- IZF
- 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 |
|---|---|---|---|
| IZF | System, X-Ray, Tomographic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZF), ordered by most recent decision date.
TAP2D
FDA 510(k)
FDA Class 2
·Radiology
Adaptix Ortho350
FDA 510(k)
FDA Class 2
·Radiology
Nanox.ARC X
FDA 510(k)
FDA Class 2
·Radiology
Nanox.ARC
FDA 510(k)
FDA Class 2
·Radiology
Nanox.ARC
FDA 510(k)
FDA Class 2
·Radiology
Ortho Device, ADAPTIX 3D Orthopedic Imaging System
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Tecnomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892226 | TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE | Apr 26, 1989 | Substantially Equivalent |
| K854203 | TEC 2720 MAMEX DC MAG | Mar 6, 1986 | Substantially Equivalent |
| K827124 | RALCO COLLIMATOR, AUTOMATIC, RADIOGRAPHIC | Mar 5, 1982 | Substantially Equivalent |
| K820306 | RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC | Mar 5, 1982 | Substantially Equivalent |
| K820307 | TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE | Mar 5, 1982 | Substantially Equivalent |
| K827126 | TECHNOMED GENERATOR, RADIOGRAPHIC, 3 PHASE | Mar 5, 1982 | Substantially Equivalent |
| K827125 | RALCO COLLIMATORS, MANUAL, RADIOGRAPHIC | Mar 4, 1982 | Substantially Equivalent |
| K820305 | RALCO COLLIMATORS, MANUAL RADIOGRAPHIC | Mar 4, 1982 | Substantially Equivalent |
| K811195 | ARGOSTAT | Jun 9, 1981 | Substantially Equivalent |
| K811196 | ALLMEC 90/15 | Jun 9, 1981 | Substantially Equivalent |