510(k) DEN220063 ยท QVD Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
Caption Interpretation Automated Ejection Fraction Software
| Applicant | Caption Health, Inc., Brisbane CA, US |
| Decision | Unknown, Feb 24, 2023 |
| Received | Sep 28, 2022 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN220063
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