FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XIO RTP SYSTEM
K Number: K102216
·
Decision Oct 1, 2010
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
23
Review Days
56
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Basic Information
- Device Name
- XIO RTP SYSTEM
- K Number
- K102216
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Computerized Medical Systems, Inc.
- Date Received
- August 6, 2010
- Decision Date
- October 1, 2010
- Product Code
- MUJ
- 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 |
|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | FDA class 2 | Radiology |
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Other Clearances by Computerized Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K110730 | MONACO RTP SYSTEM | Jun 24, 2011 | Substantially Equivalent |
| K092132 | XIO RTP SYSTEM | Sep 24, 2009 | Substantially Equivalent |
| K091179 | MONACO RTP SYSTEM, VMAT OPTION | Jul 16, 2009 | Substantially Equivalent |
| K080799 | ATLAS-BASED AUTOSEGMENTATION | Aug 7, 2008 | Substantially Equivalent |
| K071938 | MONACO RTP SYSTEM | Oct 1, 2007 | Substantially Equivalent |
| K032762 | XIO RADIATION TREATMENT PLANNING SYSTEM | Dec 2, 2003 | Substantially Equivalent |
| K032100 | I-BEAM | Oct 2, 2003 | Substantially Equivalent |
| K020027 | FOCUS RADIATION TREATMENT PLANNING SYSTEM | Oct 8, 2002 | Substantially Equivalent |
| K013112 | FOCAL SIM | Dec 5, 2001 | Substantially Equivalent |
| K002147 | FOCUS | Oct 13, 2000 | Substantially Equivalent |