FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROCESSOR, VIDEO IMAGE VIP-550
K Number: K780165
·
Decision Mar 2, 1978
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
7
Review Days
30
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Basic Information
- Device Name
- PROCESSOR, VIDEO IMAGE VIP-550
- K Number
- K780165
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Ohio Nuclear, Inc.
- Date Received
- January 31, 1978
- Decision Date
- March 2, 1978
- Product Code
- IYX
- 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 |
|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | FDA class 1 | Radiology |
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Other Clearances by Ohio Nuclear, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K792603 | COMPUTED TOMOGRAPHY X-RAY SCANNER | Jan 28, 1980 | Substantially Equivalent |
| K791195 | DELTASCAN COMPUTER TOMOGRAPHY X-RAY SCAN | Jul 30, 1979 | Substantially Equivalent |
| K781079 | SONOGRAF ULTRASOUND B-SCANNING SYSTEM | Jul 17, 1978 | Substantially Equivalent |
| K780115 | SCANNERS, TOMOGRAPHIC, COMPUTED | Jan 30, 1978 | Substantially Equivalent |
| K772305 | RAD. THERAPY PLANNING SUP. SYS. | Jan 9, 1978 | Substantially Equivalent |
| K771082 | DELTASCAN 2000 SERIES | Jun 24, 1977 | Substantially Equivalent |