XIO RTP SYSTEM
FDA 510(k) clearance K102216 · decided 2010-10-01
Clearance details
- K-number
- K102216
- Device name
- XIO RTP SYSTEM
- Applicant
- Computerized Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-08-06
- Decision date
- 2010-10-01
- Days to decision
- 56 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 |
|---|---|---|
| XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient recall (Z-1197-2014) | Elekta, Inc. | 2014-03-13 |
| XiO RTP System. Used to create treatment plans for any cancer patient for whom external be recall (Z-0928-2014) | Elekta, Inc. | 2014-02-04 |
| XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient recall (Z-0780-2014) | Elekta, Inc. | 2014-01-17 |
| XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00. Used to create treatmen recall (Z-1644-2012) | Computerized Medical Systems Inc | 2012-05-22 |
| XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and l recall (Z-2919-2011) | Computerized Medical Systems Inc | 2011-08-03 |
| XiO Radiation Treatment Planning System. XiO Release 4.50.00 and above Used to create trea recall (Z-2582-2011) | Computerized Medical Systems Inc | 2011-06-17 |