FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OMEGA 500 RECTANGULAR FIELD CAMERA W/SC
K Number: K813073
·
Decision Dec 8, 1981
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
32
Review Days
36
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Basic Information
- Device Name
- OMEGA 500 RECTANGULAR FIELD CAMERA W/SC
- K Number
- K813073
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Technicare Corp.
- Date Received
- November 2, 1981
- Decision Date
- December 8, 1981
- 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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