FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Radixact Treatment Delivery System
K Number: K161146
·
Decision Jun 24, 2016
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
21
Review Days
63
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Basic Information
- Device Name
- Radixact Treatment Delivery System
- K Number
- K161146
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Accuray Incorporated
- Date Received
- April 22, 2016
- Decision Date
- June 24, 2016
- 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 Accuray Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K223159 | Radixact Treatment Delivery System | Jun 23, 2023 | Substantially Equivalent |
| K212794 | Accuray Precision Treatment Planning System | Sep 30, 2021 | Substantially Equivalent |
| K202412 | ClearRT Helical kVCT for the Radixact Treatment Delivery System | Dec 18, 2020 | Substantially Equivalent |
| K182687 | Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System | Nov 23, 2018 | Substantially Equivalent |
| K171837 | TomoTherapy Treatment Delivery System with iDMS | Jul 25, 2017 | Substantially Equivalent |
| K171086 | Accuray Precision Treatment Planning System | Jun 8, 2017 | Substantially Equivalent |
| K161136 | Precision Treatment Planning System | Jun 24, 2016 | Substantially Equivalent |
| K161144 | iDMS Data Management System | Jun 24, 2016 | Substantially Equivalent |
| K152488 | Onrad Treatment System | Sep 28, 2015 | Substantially Equivalent |
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