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De Novo DEN170073
- Device
- ContaCT
- Contact
- gregory ramina
- De Novo number
- DEN170073
- Product code
- QAS
- Regulation
- 892.2080
- Classification name
- radiological computer-assisted triage and notification software
- Decision
- granted (DENG)
- Decision date
- 2018-02-13
- Date received
- 2017-09-29
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- QAS
- Device name
- Radiological Computer-Assisted Triage And Notification Software
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.2080
- Implant
- N
- Life sustain/support
- N