FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VARIAN RADIATION THERAPY IMAGING SYSTEM
K Number: K971839
·
Decision Aug 15, 1997
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
69
Applicant Total
85
Review Days
88
Basic Information
- Device Name
- VARIAN RADIATION THERAPY IMAGING SYSTEM
- K Number
- K971839
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5840
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VARIAN MEDICAL SYSTEMS, INC.
- Date Received
- May 19, 1997
- Decision Date
- August 15, 1997
- Product Code
- KPQ
- 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 |
|---|---|---|---|
| KPQ | System, Simulation, Radiation Therapy | FDA class 2 | Radiology |
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