Skip to contentDe Novo DEN220040
- Device
- Fibresolve
- Contact
- joshua reicher
- De Novo number
- DEN220040
- Product code
- QWO
- Regulation
- 892.2085
- Classification name
- radiology software for referral of findings related to fibrotic lung disease.
- Decision
- granted (DENG)
- Decision date
- 2024-01-12
- Date received
- 2022-06-29
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- QWO
- Device name
- Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.2085
- Implant
- N
- Life sustain/support
- N