K243065 is an FDA 510(k) clearance for the Cardiac Guidance. This device is classified as a Image Acquisition And/or Optimization Guided By Artificial Intelligence (Class II - Special Controls, product code QJU).
Submitted by Caption Health, Inc. (San Mateo, US). The FDA issued a Cleared decision on January 15, 2025, 110 days after receiving the submission on September 27, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2100. 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..
| 510(k) Number | K243065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2024 |
| Decision Date | January 15, 2025 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | QJU - Image Acquisition And/or Optimization Guided By Artificial Intelligence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2100 |
| Definition | 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. |