# K253026: Respiratory Gating for Scanners (2.1)

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jun 4, 2026 after 258 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K864886 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213927: Respiratory Gating for Scanners v2.0, Varian Medical Systems, Inc. (2022) Summary page 5.

## Indications for use
Respiratory Gating for Scanners (RGSC) is used to characterize the patient’s respiratory patterns, providing the necessary information to diagnostic devices to acquire images synchronized with the breathing motion. RGSC can also be used to monitor the patient position during the image acquisition.

Source page: https://510kreport.com/device/K253026
Methodology: https://510kreport.com/methodology