| K-number | K242957 |
| Device name | Identify (4.0) |
| Applicant | Varian Medical Systems, Inc. |
| Product code | IYE |
| Device class | Class II |
| Decision date | Feb 7, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.5050 |
IDENTIFY (4.0) is a patient motion monitoring system for radiotherapy treatment simulation and delivery. It uses high-precision cameras to track patient positioning, monitor respiratory patterns, and detect intra-fraction position changes, with capability to output data to radiotherapy devices for synchronizing image acquisition or treatment delivery.
The device includes four significant enhancements over the predicate: TrueBeam Couch Control for automated couch position correction, optional handheld free workflow capability, SRS mode for switching display scale from centimeters to millimeters, and Planning Tool accessibility on the ARIA workstation. No changes were made to the principle of operation.
Hardware and software verification and validation testing per FDA Quality System Regulation (21 CFR 820), ISO 13485, ISO 14971, and IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). Additional standards include ISO 14971:2019, IEC 62304:2006+A1:2015, IEC 61217:2011, and IEC 80001-1:2021, among others.
Varian argues that the technological differences between IDENTIFY (4.0) and its predicate are enhancements only, with no changes to the device's fundamental operating principle. Verification and validation testing demonstrated the device is as safe and effective as the predicate, with no unresolved anomalies of Safety Intolerable or Customer Intolerable priority, establishing substantial equivalence.
View the full FDA submission: accessdata.fda.gov