# K082773: Standard Imaging Imsure Brachy QA Software, Model 91331

- Pathway: 510(k) (Traditional)
- Applicant: Standard Imaging, Inc.
- Decided: Nov 19, 2008 after 58 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: 4 generations back to K914698 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031975: Imsure, Prodigm, Inc. (2003) Summary page 1.
- K061152: Mucheck V7.0, Oncology Data Systems, Inc. (2006) Summary page 1.

## Indications for use
IMSure Brachy QA Software is a stand alone software application product intended for use as a quality assurance tool to verify brachytherapy treatment plans developed on a radiation therapy treatment planning system with the appropriate transfer format. It may also be used as a segregated standalone application in the IMSure QA Software suite of software products. This product is intended for use by trained medical physicists, physicians, or dosimetrists. The calculation results must be evaluated by qualified personnel before a patient treatment. It is the responsibility of the medical physicist, physician or dosimetrist to determine whether the dosimetric accuracy is adequate for a particular patient. Dose modeling of a source is based on the AAPM TG-43 formalism, and may be adjusted to match measured or published results. IMSure Brachy QA Software does not control any radiation delivery devices and does not allow the export of calculated information.

Source page: https://510kreport.com/device/K082773
Methodology: https://510kreport.com/methodology