# K090531: Radcalc Software, Version 6.0

- Pathway: 510(k) (Traditional)
- Applicant: Lifeline Software, Inc.
- Decided: May 27, 2009 after 89 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: 4 generations back to K914698 (1992). 7 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061152: Mucheck V7.0, Oncology Data Systems, Inc. (2006) Summary page 1.
- K010464: Radcalc, Model V.4.0, Lifeline Software, Inc. (2001) Summary page 1.

## Most influential descendants
- K153014: Mobius3D (2016), 13 descendants of its own
- K191761: Mobius3D (2019), 5 descendants of its own
- K192424: Mobius3D (2019), 4 descendants of its own
- K171350: Collision Check (2017), 4 descendants of its own
- K220583: ClearCheck Model RADCC V2 (2022), 3 descendants of its own

## Indications for use
RadCalc Software is a program utilized in a radiation therapy department for the determination of monitor units and/or the dose to various points of interest for external beam radiation therapy and/or brachytherapy treatments. For external beam treatments, RadCalc's monitor unit calculation can be used to validate the monitor units or dose previously determined by hand or by the primary radiation therapy planning system. RadCalc's function is to support the primary radiation therapy planning computer by validating its calculation as a means of quality assurance. RadCalc Software not only performs this secondary function but can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy treatment plan. RadCalc Software imports treatment planning parameters from the primary treatment planning system or a verify and record system; parameters can also be entered manually. The dosimetric calculations are then performed for photon or electron external beam radiation plans or LDR, HDR, and Permanent Implant brachytherapy treatment plans. The brachytherapy treatment module is only used to validate the dose to points of interest and not for brachytherapy treatment planning. RadCalc Software allows for the transfer of the treatment planning data from the primary radiation therapy planning computer or the Verify and Record system (system actually controlling the radiation beam) to RadCalc and then to the facility's Verify and Record system or radiation therapy planning computer. This electronic transfer of treatment planning data reduces the number of errors that could occur as a result of manually inputting the data.

Source page: https://510kreport.com/device/K090531
Methodology: https://510kreport.com/methodology