FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
SENTINEL
K Number: K120668
·
Decision Jul 30, 2012
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
6
Review Days
147
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Basic Information
- Device Name
- SENTINEL
- K Number
- K120668
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C-Rad Positioning AB
- Date Received
- March 5, 2012
- Decision Date
- July 30, 2012
- 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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Other Clearances by C-Rad Positioning AB
| K Number | Device Name | ||
|---|---|---|---|
| K200435 | Catalyst+, Catalyst+ HD | May 7, 2020 | Substantially Equivalent |
| K200600 | Sentinel | Apr 20, 2020 | Substantially Equivalent |
| K113276 | CATALYST | Feb 27, 2012 | Substantially Equivalent |
| K082582 | SENTINEL, MODEL SP-001 | Mar 30, 2009 | Substantially Equivalent |
| K063839 | POSITIONER | Feb 8, 2007 | Substantially Equivalent |