ChartCheck (RADCH V1.6)
FDA 510(k) K252988 · Radformation, Inc.
510(k) numberK252988
Submission
- Device name
- ChartCheck (RADCH V1.6)
- Applicant
- Radformation, Inc.
New York, NY, US - Received
- September 18, 2025
- Decision date
- January 5, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Varian Medical Systems, Inc.
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| K262452 | AutoContour (RADAC V6)QKB · Special | 08/14/2026SE |
| K253962 | ClearCheck (RADCC V2.7)IYE · Traditional | 04/03/2026SE |
| K260509 | AutoContour (RADAC V5)QKB · Special | 03/19/2026SE |
| K252863 | ClearCalc Model RADCA V2.6MUJ · Traditional | 12/19/2025SE |
| K242729 | AutoContour (Model RADAC V4)QKB · Traditional | 12/09/2024SE |
| K230685 | AutoContour Model RADAC V3QKB · Special | 04/14/2023SE |
| K220598 | AutoContour Model RADAC V2QKB · Traditional | 08/24/2022SE |
| K220583 | ClearCheck Model RADCC V2IYE · Traditional | 08/23/2022SE |
| K220582 | ClearCalc Model RADCA V2MUJ · Traditional | 08/22/2022SE |
Questions and answers
When was ChartCheck (RADCH V1.6) cleared by the FDA?
ChartCheck (RADCH V1.6) (K252988) received a 510(k) decision of Substantially Equivalent on January 5, 2026, 109 days after the submission was received.
What is the product code of K252988?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.