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De Novo DEN200080
- Device
- Paige Prostate
- Contact
- emre gulturk
- De Novo number
- DEN200080
- Product code
- QPN
- Regulation
- 864.3750
- Classification name
- software algorithm device to assist users in digital pathology
- Decision
- granted (DENG)
- Decision date
- 2021-09-21
- Date received
- 2020-12-31
- Classification advisory
- Pathology
- Review advisory
- Pathology
- Type
- Direct
Current FDA Classification#
- Product code
- QPN
- Device name
- Software Algorithm Device To Assist Users In Digital Pathology
- Medical specialty
- Pathology
- Device class
- 2
- Regulation
- 864.3750
- Implant
- N
- Life sustain/support
- N