# K052383: Innocure Imrt Filter (Compensators)

- Pathway: 510(k) (Traditional)
- Applicant: Innocure, LLC
- Decided: Mar 29, 2006 after 211 days
- Product code: IXI (Block, Beam-Shaping, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5710
- 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 K000137 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040804: .Decimal Tissue Compensator/Intensity Modulator, Southeastern Radiation Products, Inc. (2004) Summary page 2.

## Indications for use
Innocure Intensity Modulating Radiation Therapy Compensators are indicated to be used for external beam radiation therapy to modulate the intensity and shape of a radiation beam to compensate for missing tissue, for tissue heterogeneities, or to protect underlying tissue by intensity modulation, i.e. Intensity Modulated Radiation Therapy (IMRT).

Source page: https://510kreport.com/device/K052383
Methodology: https://510kreport.com/methodology