FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C
K Number: K090044
·
Decision Jan 22, 2009
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
2
Review Days
15
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Basic Information
- Device Name
- PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C
- K Number
- K090044
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oncolog Medical QA AB
- Date Received
- January 7, 2009
- Decision Date
- January 22, 2009
- Product Code
- IYE
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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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Other Clearances by Oncolog Medical QA AB
| K Number | Device Name | ||
|---|---|---|---|
| K092939 | PATLOG 2.0 | Oct 9, 2009 | Substantially Equivalent |