FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ChartCheck (RADCH V1.6)
K Number: K252988
·
Decision Jan 5, 2026
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
14
Review Days
109
Basic Information
- Device Name
- ChartCheck (RADCH V1.6)
- K Number
- K252988
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radformation, Inc.
- Date Received
- September 18, 2025
- Decision Date
- January 5, 2026
- 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 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 |
| K252863 | ClearCalc Model RADCA V2.6 | Dec 19, 2025 | Substantially Equivalent |
| K242729 | AutoContour (Model RADAC V4) | Dec 9, 2024 | Substantially Equivalent |
| K230685 | AutoContour Model RADAC V3 | Apr 14, 2023 | 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 |