ClearCalc
FDA 510(k) clearance K193640 · decided 2020-04-09
Clearance details
- K-number
- K193640
- Device name
- ClearCalc
- Applicant
- Radformation, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-27
- Decision date
- 2020-04-09
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- MUJ
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Virtual Cone (1.0) (K260750) | Varian Medical Systems, Inc. | 2026-07-08 |
| RadOncAI (K253050) | Informai | 2026-06-18 |
| Multimodality Simulation Workspace (MM Sim) (v1.0.0) (K260207) | Philips Medical Systems Nederland B.V. | 2026-05-27 |
| eXaSkin Plus (K252784) | Anatomical Geometry S.L. | 2026-05-22 |
| ART.1-US (K253078) | Seetreat Pty, Ltd. | 2026-05-14 |
| syngo.via RT Image Suite VC10 (K252304) | Varian Medical Systems, Inc. | 2026-03-18 |
| TrueFit Bolus (K260308) | Adaptiiv Medical Technologies, Inc. | 2026-02-19 |
| Monaco RTP System (6.3) (K252002) | Elekta Solutions AB | 2026-02-19 |
| ART-Plan+ (v3.1.0) (K253091) | Therapanacea Sas | 2025-12-23 |
| RayStation (2024A SP3) (K252109) | RaySearch Laboratories AB (PUBL) | 2025-12-22 |
| ClearCalc Model RADCA V2.6 (K252863) | Radformation, Inc. | 2025-12-19 |
| PlanOne 1 (K250963) | Cosylab Jsc, Control System Laboratory | 2025-11-20 |
Recalls involving this device
No recalls on record reference this clearance.