FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
HELAX-IMCON, VERSION 1.0
K Number: K982857
·
Decision Nov 4, 1998
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
69
Applicant Total
3
Review Days
83
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Basic Information
- Device Name
- HELAX-IMCON, VERSION 1.0
- K Number
- K982857
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5840
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Helax AB
- Date Received
- August 13, 1998
- Decision Date
- November 4, 1998
- 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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