FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLINIX-R TOMOGRAPHIC DEVICE
K Number: K810274
·
Decision Mar 11, 1981
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
39
Applicant Total
181
Review Days
37
Basic Information
- Device Name
- CLINIX-R TOMOGRAPHIC DEVICE
- K Number
- K810274
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1740
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
- Date Received
- February 2, 1981
- Decision Date
- March 11, 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 |
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