# K162629: IQM Integral Quality Monitor (also IQM)

- Pathway: 510(k) (Traditional)
- Applicant: Irt Systems
- Decided: Oct 20, 2016 after 29 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: 3 generations back to K874893 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062817: PTW David Imrt QC Verification System, Ptw-New York Corp. (2006) Summary page 4.

## Indications for use
The IQM Integral Quality Monitor is a large-area ionization chamber intended to be used for quality assurance verification measurements and documentation of the treatment delivery accuracy (beam shape, position and dose) from medical linear accelerators used for intensity modulated radiation therapy. The data acquired by IQM is used to compare and verify a treatment dose (delivered dose) to the expected dose and to compile treatment delivery radiation beam data over time as part of a quality assurance program.

Source page: https://510kreport.com/device/K162629
Methodology: https://510kreport.com/methodology