# K040804: .Decimal Tissue Compensator/Intensity Modulator

- Pathway: 510(k) (Traditional)
- Applicant: Southeastern Radiation Products, Inc.
- Decided: Apr 28, 2004 after 30 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: 2 generations back to K000137 (2000). 6 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000137: Enhanced Compensating Filter, Computerized Medical Systems, Inc. (2000) Summary page 1.
- K940412: Multileaf Intensity Modulating Collimator, Nomos Corp. (1995) Summary page 1.
- K943224: Varian Multileaf Collimator, Varian Assoc., Inc. (1996) Summary page 1.
- K021987: Parcomplast Compensating Filter for Radiation Therapy, S&S Par Scientific (2002) Summary page 1.
- K880047: Huestis Compu-Former, Huestis Machine Corp. (1988) Summary page 1.

## Most influential descendants
- K071078: .Decimal Range Compensator (2007), 9 descendants of its own
- K091911: Bolus Compensator (2009), 5 descendants of its own
- K071077: .Decimal Aperture (2007), 4 descendants of its own
- K214093: VSP Bolus (2022), 2 descendants of its own
- K121657: Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy Beam-Shping Range Compensator (2012), 2 descendants of its own

## Indications for use
.decimal tissue compensator/intensity modulator manufacturing service manufactures the solid filters for missing tissue and intensity modulation for external beam radiation therapy.

Source page: https://510kreport.com/device/K040804
Methodology: https://510kreport.com/methodology