FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AutoContour Model RADAC V3
K Number: K230685
·
Decision Apr 14, 2023
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
45
Applicant Total
14
Review Days
32
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Basic Information
- Device Name
- AutoContour Model RADAC V3
- K Number
- K230685
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radformation, Inc.
- Date Received
- March 13, 2023
- Decision Date
- April 14, 2023
- Product Code
- QKB
- 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 |
|---|---|---|---|
| QKB | Radiological Image Processing Software For Radiation Therapy | FDA class 2 | Radiology |
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Other Clearances by Radformation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253962 | ClearCheck (RADCC V2.7) | Apr 3, 2026 | Substantially Equivalent |
| K260509 | AutoContour (RADAC V5) | Mar 19, 2026 | Substantially Equivalent |
| K252988 | ChartCheck (RADCH V1.6) | Jan 5, 2026 | Substantially Equivalent |
| K252863 | ClearCalc Model RADCA V2.6 | Dec 19, 2025 | Substantially Equivalent |
| K242729 | AutoContour (Model RADAC V4) | Dec 9, 2024 | Substantially Equivalent |
| K220598 | AutoContour Model RADAC V2 | Aug 24, 2022 | Substantially Equivalent |
| K220583 | ClearCheck Model RADCC V2 | Aug 23, 2022 | Substantially Equivalent |
| K220582 | ClearCalc Model RADCA V2 | Aug 22, 2022 | Substantially Equivalent |
| K200323 | AutoContour | Oct 30, 2020 | Substantially Equivalent |
| K201119 | ChartCheck | Jun 26, 2020 | Substantially Equivalent |