# K012575: Prefernce Imrt Treatment Planning Module

- Pathway: 510(k) (Traditional)
- Applicant: Northwest Medical Physics Equipment, Inc.
- Decided: Mar 12, 2002 after 215 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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: 2 generations back to K970464 (1997). 2 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970464: P Reference TPS (Treatment Planning Software) 1.1, Northwest Medical Physics Equipment, Inc. (1997) Summary page 3.
- K983793: Preference Treatment System, Northwest Medical Physics Equipment, Inc. (1999) Summary page 3.

## Most influential descendants
- K060906: Calypso 4D Localization System (2006), 11 descendants of its own
- K080726: Calypso 4D Localization System (2008), 9 descendants of its own
- K102373: Calypso System with Dynamic Edge Gating (2010), 6 descendants of its own
- K112768: Calypso Systems with Dynamic Edge Gating (2011), 4 descendants of its own
- K123137: Calypso System (2012), 3 descendants of its own

## Indications for use
The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas. The expanded indications for use are also applicable as previously presented for pReference Treatment System (K983793), including hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors. The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target with respect to implanted fiducials, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

Source page: https://510kreport.com/device/K012575
Methodology: https://510kreport.com/methodology