510(k) K243065
K243065 is an FDA 510(k) premarket notification submitted by Caption Health, Inc. for the device "Cardiac Guidance". The FDA issued a decision of Substantially Equivalent on Jan 15, 2025. The device falls under product code QJU (Image Acquisition And/Or Optimization Guided By Artificial Intelligence), a Class II device regulated under 21 CFR 892.2100. Caption Health, Inc. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 15, 2025
- Date Received
- Sep 27, 2024
- Clearance Type
- Traditional
- 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
- 510(k)
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.