ARIA RADIATION ONCOLOGY WITH MIRS
FDA 510(k) clearance K093527 · decided 2009-12-15
Clearance details
- K-number
- K093527
- Device name
- ARIA RADIATION ONCOLOGY WITH MIRS
- Applicant
- Varian Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-11-16
- Decision date
- 2009-12-15
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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