FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE
K Number: K820307
·
Decision Mar 5, 1982
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
162
Applicant Total
18
Review Days
29
Basic Information
- Device Name
- TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE
- K Number
- K820307
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- TECNOMED, INC.
- Date Received
- February 4, 1982
- Decision Date
- March 5, 1982
- Product Code
- IZO
- 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZO), ordered by most recent decision date.
MPH50, MPH65, AND MPH80
FDA 510(k)
FDA Class 1
·Radiology
HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
FDA 510(k)
FDA Class 1
·Radiology
N 800 HF
FDA 510(k)
FDA Class 1
·Radiology
SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G
FDA 510(k)
FDA Class 1
·Radiology
MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR
FDA 510(k)
FDA Class 1
·Radiology
POLYDOROS SX 65 AND 80
FDA 510(k)
FDA Class 1
·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 |
| K827126 | TECHNOMED GENERATOR, RADIOGRAPHIC, 3 PHASE | Mar 5, 1982 | Substantially Equivalent |
| K827124 | RALCO COLLIMATOR, AUTOMATIC, RADIOGRAPHIC | Mar 5, 1982 | Substantially Equivalent |
| K820306 | RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC | Mar 5, 1982 | Substantially Equivalent |
| K820305 | RALCO COLLIMATORS, MANUAL RADIOGRAPHIC | Mar 4, 1982 | Substantially Equivalent |
| K827125 | RALCO COLLIMATORS, MANUAL, RADIOGRAPHIC | Mar 4, 1982 | Substantially Equivalent |
| K811195 | ARGOSTAT | Jun 9, 1981 | Substantially Equivalent |
| K811197 | SUPERIX 120 | Jun 9, 1981 | Substantially Equivalent |
| K811196 | ALLMEC 90/15 | Jun 9, 1981 | Substantially Equivalent |