FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MRIdian Linac System
K Number: K212958
·
Decision Dec 14, 2021
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
6
Review Days
89
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Basic Information
- Device Name
- MRIdian Linac System
- K Number
- K212958
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Viewray, Incorporated
- Date Received
- September 16, 2021
- Decision Date
- December 14, 2021
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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Other Clearances by Viewray, Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K181989 | MRIdian Linac System | Feb 20, 2019 | Substantially Equivalent |
| K170751 | MRIdian Linac System with 138-leaf Collimator | Jun 7, 2017 | Substantially Equivalent |
| K162393 | The ViewRay (MRIdian) Linac System | Feb 24, 2017 | Substantially Equivalent |
| K111862 | VIEWRAY SYSTEM | May 22, 2012 | Substantially Equivalent |
| K102915 | VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM | Jan 12, 2011 | Substantially Equivalent |