MONACO RTP SYSTEM
FDA 510(k) clearance K110730 · decided 2011-06-24
Clearance details
- K-number
- K110730
- Device name
- MONACO RTP SYSTEM
- Applicant
- Computerized Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-16
- Decision date
- 2011-06-24
- Days to decision
- 100 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 RTP System Radiation treatment planning recall (Z-2276-2013) | Elekta, Inc. | 2013-09-25 |
| Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment plannin recall (Z-2277-2013) | Elekta, Inc. | 2013-09-25 |
| Monaco RTP System. Radiation treatment planning. recall (Z-0841-2013) | Elekta, Inc. | 2013-02-20 |
| Monaco Product Usage: Planning of radiation therapy recall (Z-2007-2012) | Elekta, Inc. | 2012-07-12 |
| Monaco Radiation Treatment Planning System, Version 3.10.00. Planning of radiation therapy recall (Z-1365-2012) | Computerized Medical Systems Inc | 2012-04-03 |