FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
OMNIDOS
K Number: K011763
·
Decision Sep 5, 2001
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- OMNIDOS
- K Number
- K011763
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scanditronix Medical AB
- Date Received
- June 7, 2001
- Decision Date
- September 5, 2001
- 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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