ClearCalc
FDA 510(k) K193640 · Radformation, Inc.
510(k) numberK193640
Submission
- Device name
- ClearCalc
- Applicant
- Radformation, Inc.
New York, NY, US - Received
- December 27, 2019
- Decision date
- April 9, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MUJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260750 | Virtual Cone (1.0)MUJ · Traditional | Varian Medical Systems, Inc. | 07/08/2026SE |
| K253050 | RadOncAIMUJ · Traditional | Informai | 06/18/2026SE |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0)MUJ · Traditional | Philips Medical Systems Nederland B.V. | 05/27/2026SE |
| K252784 | eXaSkin PlusMUJ · Traditional | Anatomical Geometry S.L. | 05/22/2026SE |
| K253078 | ART.1-USMUJ · Traditional | Seetreat Pty, Ltd. | 05/14/2026SE |
| K252304 | syngo.via RT Image Suite VC10MUJ · Traditional | Varian Medical Systems, Inc. | 03/18/2026SE |
| K260308 | TrueFit BolusMUJ · Special | Adaptiiv Medical Technologies, Inc. | 02/19/2026SE |
| K252002 | Monaco RTP System (6.3)MUJ · Traditional | Elekta Solutions AB | 02/19/2026SE |
| K253091 | ART-Plan+ (v3.1.0)MUJ · Traditional | Therapanacea Sas | 12/23/2025SE |
| K252109 | RayStation (2024A SP3)MUJ · Traditional | RaySearch Laboratories AB (PUBL) | 12/22/2025SE |
More from RaySearch Laboratories AB (PUBL)
| 510(k) | Device | Decision |
|---|---|---|
| K261718 | EZFluence (RADEZ V2)IYE · Traditional | 08/31/2026SE |
| 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 |
| K252988 | ChartCheck (RADCH V1.6)IYE · Traditional | 01/05/2026SE |
| 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 |
Questions and answers
When was ClearCalc cleared by the FDA?
ClearCalc (K193640) received a 510(k) decision of Substantially Equivalent on April 9, 2020, 104 days after the submission was received.
What is the product code of K193640?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.