MONACO RTP SYSTEM, VMAT OPTION
FDA 510(k) clearance K091179 · decided 2009-07-16
Clearance details
- K-number
- K091179
- Device name
- MONACO RTP SYSTEM, VMAT OPTION
- Applicant
- Computerized Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-23
- Decision date
- 2009-07-16
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- MUJ
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Maryland Heights, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above To creat recall (Z-2598-2011) | Computerized Medical Systems Inc | 2011-06-20 |
| Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above. Used to recall (Z-2569-2011) | Computerized Medical Systems Inc | 2011-06-15 |
| Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. Used to cr recall (Z-2560-2011) | Computerized Medical Systems Inc | 2011-06-14 |
| Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The Mon recall (Z-2561-2011) | Computerized Medical Systems Inc | 2011-06-14 |
| Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above Used to create recall (Z-2564-2011) | Computerized Medical Systems Inc | 2011-06-14 |