# K031975: Imsure

- Pathway: 510(k) (Traditional)
- Applicant: Prodigm, Inc.
- Decided: Aug 29, 2003 after 64 days
- Product code: IYE (Accelerator, Linear, Medical)
- 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: 1 generation back to K010464 (2001). 1 ancestor in all.
6 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010464: Radcalc, Model V.4.0, Lifeline Software, Inc. (2001)

## Most influential descendants
- K191944: MU2net (2019), 2 descendants of its own
- K231573: ThinkQA (Edition 2) (2024), 1 descendant of its own
- K082606: Commissioning Data Management System (CDMS) (2008), 1 descendant of its own
- K252937: ThinkQA 3 (2026), 0 descendants of its own
- K090182: Module Integrated Radiotherapy System (Mirs) (2009), 0 descendants of its own

## Indications for use
IMSure is indicated for use as a quality assurance tool to verify IMRT treatment plans developed on any radiation therapy treatment planning system with the appropriate transfer format. IMSure will also perform primary monitor unit calculations from measured physics data for plans of known geometry.

Source page: https://510kreport.com/device/K031975
Methodology: https://510kreport.com/methodology