# K193640: ClearCalc

- Pathway: 510(k) (Traditional)
- Applicant: Radformation, Inc.
- Decided: Apr 9, 2020 after 104 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K914698 (1992). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090531: Radcalc Software, Version 6.0, Lifeline Software, Inc. (2009) Summary page 5.

## Most influential descendants
- K220582: ClearCalc Model RADCA V2 (2022), 1 descendant of its own
- K252863: ClearCalc Model RADCA V2.6 (2025), 0 descendants of its own

## Indications for use
ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.

Source page: https://510kreport.com/device/K193640
Methodology: https://510kreport.com/methodology