DEN220063 is an FDA 510(k) submission for the Caption Interpretation Automated Ejection Fraction Software. This device is classified as a Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan (Class II - Special Controls, product code QVD).
Submitted by Caption Health, Inc. (Brisbane, US). The FDA issued a Not Cleared (DENG) decision on February 24, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2055. A Radiological Machine Learning Quantitative Imaging Software With Predetermined Change Control Plan Is A Software-only Device Which Employs Machine Learning Algorithms On Radiological Images To Provide Quantitative Imaging Outputs. The Device Includes Functions To Support Outputs Such As View Selection, Segmentation And Landmarking. The Design Specifications Include Planned Modifications That May Be Made To The Device Consistent With An Established Predetermined Change Control Plan..
| 510(k) Number | DEN220063 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 28, 2022 |
| Decision Date | February 24, 2023 |
| Days to Decision | 149 days |
| Submission Type | Direct |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | QVD - Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2055 |
| Definition | A Radiological Machine Learning Quantitative Imaging Software With Predetermined Change Control Plan Is A Software-only Device Which Employs Machine Learning Algorithms On Radiological Images To Provide Quantitative Imaging Outputs. The Device Includes Functions To Support Outputs Such As View Selection, Segmentation And Landmarking. The Design Specifications Include Planned Modifications That May Be Made To The Device Consistent With An Established Predetermined Change Control Plan. |