# K063270: RPM Respiratory Gating System

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Dec 14, 2006 after 45 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K864886 (1987). 2 ancestors in all.
83 later devices descend from it; 4 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983629: RPM Respiratory Gating System, Varian Medical Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K092871: Trilogy MX (2009), 61 descendants of its own
- K111106: Truebeam (2011), 43 descendants of its own
- K123291: Truebeam (2012), 37 descendants of its own
- K123808: Agility (2013), 36 descendants of its own
- K140528: True Beam, True Beam STX, Edge (2014), 31 descendants of its own

## Recalls of this device
- Sep 26, 2007 · Not classified · Z-0554-2008: Erroneously Resetting: RPM System version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. RPM 1.7 erroneously resets the phase-based ga

## Indications for use
The RPM Respiratory Gating System is used to obtain tracking of the subject respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. It can be also used to monitor the patient position during the image acquisition, simulation and treatment.

Source page: https://510kreport.com/device/K063270
Methodology: https://510kreport.com/methodology