Galen™ Second Read™
FDA 510(k) clearance K241232 · decided 2025-01-24
Clearance details
- K-number
- K241232
- Device name
- Galen™ Second Read™
- Applicant
- Ibex Medical Analytics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-05-02
- Decision date
- 2025-01-24
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- QPN
- Device class
- 2
- Regulation number
- 864.3750
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Tel Aviv, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Paige Prostate (DEN200080) | Paige.Ai | 2021-09-21 |
Recalls involving this device
No recalls on record reference this clearance.