Identify (4.0)
Varian Medical Systems, Inc.Identify (4.0) is a medical device by Varian Medical Systems designed to monitor patient motion and respiratory patterns during radiotherapy treatment simulation and delivery. Using high precision surface guided radiation therapy cameras, it helps clinicians accurately position patients and detect motion during treatment, enhancing patient safety and treatment accuracy by synchronizing imaging and radiation delivery with patient motion data.
Intended Use
IDENTIFY is intended for patient motion monitoring, including monitoring of respiratory patterns during radiotherapy treatment simulation and delivery. It outputs data to synchronize image acquisition or treatment delivery with acquired motion information.
Technology
IDENTIFY incorporates high precision surface guided radiation therapy (SGRT) cameras to monitor respiratory motion and detect intra-fraction position changes during radiotherapy. It supports patient positioning, safety, quality, and workflow efficiency, with features like TrueBeam couch control and planning tool accessibility.
Performance
The device underwent hardware and software verification and validation testing according to FDA and ISO standards. Testing showed conformance to requirements with no unresolved safety issues. Software was classified as major level of concern with enhanced documentation. Electrical safety and EMC testing were conducted and complied with IEC 60601-1 standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/25/2024
4 months - 2
FDA Approval
2/7/2025
Other devices from Varian Medical Systems, Inc.
- Mobius3D (4.1)2025 • 510K
- CT/ MR Tandem and Ovoid Set2025 • 510K
- Intracavitary/Interstitial System2025 • 510K
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