FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
HELAX-VISIR
K Number: K972617
·
Decision Oct 1, 1997
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
3
Review Days
84
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Basic Information
- Device Name
- HELAX-VISIR
- K Number
- K972617
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Helax AB
- Date Received
- July 9, 1997
- Decision Date
- October 1, 1997
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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