xR IVD
FDA 510(k) clearance K241868 · decided 2025-09-19
Clearance details
- K-number
- K241868
- Device name
- xR IVD
- Applicant
- Tempus AI, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-06-27
- Decision date
- 2025-09-19
- Days to decision
- 449 days
- Clearance type
- Traditional
- Product code
- PZM
- Device class
- 2
- Regulation number
- 866.6080
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| xT CDx (P210011/S003) | Tempus AI, Inc. | 2025-06-27 |
| xT CDx (P210011/S001) | Tempus AI, Inc. | 2023-06-07 |
| xT CDx (P210011) | Tempus AI, Inc. | 2023-04-28 |