FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOMOMATIC 232
K Number: K862511
·
Decision Jul 10, 1987
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
5
Review Days
374
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Basic Information
- Device Name
- TOMOMATIC 232
- K Number
- K862511
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Medimatic
- Date Received
- July 1, 1986
- Decision Date
- July 10, 1987
- Product Code
- KPS
- 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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | FDA class 2 | Radiology |
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