510(k) K260780
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2026
- Date Received
- March 10, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Image Acquisition And/Or Optimization Guided By Artificial Intelligence
- Device Class
- Class II
- Regulation Number
- 892.2100
- Review Panel
- RA
- Submission Type
A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.