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De Novo DEN170022
- Device
- QuantX
- Contact
- robert tomek
- De Novo number
- DEN170022
- Product code
- POK
- Regulation
- 892.2060
- Classification name
- computer-assisted diagnostic software for lesions suspicious for cancer
- Decision
- granted (DENG)
- Decision date
- 2017-07-19
- Date received
- 2017-04-07
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- POK
- Device name
- Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.2060
- Implant
- N
- Life sustain/support
- N