FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ClearCalc
K Number: K193640
·
Decision Apr 9, 2020
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
14
Review Days
104
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ClearCalc
- K Number
- K193640
- 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
- December 27, 2019
- Decision Date
- April 9, 2020
- Product Code
- MUJ
- 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 |
|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUJ), ordered by most recent decision date.
RadOncAI
FDA 510(k)
FDA Class 2
·Radiology
Multimodality Simulation Workspace (MM Sim) (v1.0.0)
FDA 510(k)
FDA Class 2
·Radiology
eXaSkin Plus
FDA 510(k)
FDA Class 2
·Radiology
ART.1-US
FDA 510(k)
FDA Class 2
·Radiology
syngo.via RT Image Suite VC10
FDA 510(k)
FDA Class 2
·Radiology
TrueFit Bolus
FDA 510(k)
FDA Class 2
·Radiology
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 |
| 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 |