Skip to contentDe Novo DEN230020
- Device
- BioTraceIO Lite
- Contact
- dalia dickman
- De Novo number
- DEN230020
- Product code
- QZL
- Regulation
- 892.2052
- Classification name
- post-ablation tissue response prediction software
- Decision
- granted (DENG)
- Decision date
- 2023-12-22
- Date received
- 2023-03-30
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- QZL
- Device name
- Post-Ablation Tissue Response Prediction Software
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.2052
- Implant
- N
- Life sustain/support
- N