510(k) DEN200080
- Device
- Paige Prostate
- Applicant
- Paige.Ai
- 510(k) number
- DEN200080
- Product code
- QPN
- Decision
- Unknown (DENG)
- Decision date
- 2021-09-21
- Date received
- 2020-12-31
- Regulation
- 864.3750
- Classification name
- Software Algorithm Device To Assist Users In Digital Pathology
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Emre Gulturk
- Address
- 11 Times Sq. 37th Floor New York NY US 10036 10036
FDA Registration Numbers#
- 3017125738
- 3029787717
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QPN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241232 | Galen™ Second Read™ | Ibex Medical Analytics , Ltd. | 2025-01-24 |