510(k) K241232
- Device
- Galen? Second Read?
- Applicant
- Ibex Medical Analytics , Ltd.
- 510(k) number
- K241232
- Product code
- QPN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-24
- Date received
- 2024-05-02
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Yael Liebes Peer
- Address
- 101 Rokach Blvd. Tel Aviv IL 6153101 6153101
FDA Registration Numbers#
- 3029787717
- 3017125738
Source Documents#
Other 510(k) Records For Product Code QPN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN200080 | Paige Prostate | Paige.Ai | 2021-09-21 |