De Novo DEN220063
- Device
- Caption Interpretation Automated Ejection Fraction Software
- Contact
- tahir rizvi
- De Novo number
- DEN220063
- Product code
- QVD
- Regulation
- 892.2055
- Classification name
- radiological machine learning based quantitative imaging software with change control plan
- Decision
- granted (DENG)
- Decision date
- 2023-02-24
- Date received
- 2022-09-28
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- QVD
- Device name
- Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.2055
- Implant
- N
- Life sustain/support
- N