510(k) DEN220063
- Device
- Caption Interpretation Automated Ejection Fraction Software
- Applicant
- Caption Health, Inc.
- 510(k) number
- DEN220063
- Product code
- QVD
- Decision
- Unknown (DENG)
- Decision date
- 2023-02-24
- Date received
- 2022-09-28
- Regulation
- 892.2055
- Classification name
- Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Tahir Rizvi
- Address
- 2000 Sierra Pt. Pkwy., 8th Floor Brisbane CA US 94005 94005
FDA Registration Numbers#
- 3032008018
Source Documents#
510(k) summary PDF not indicated by FDA