BioTraceIO Precision (2.0)
FDA 510(k) clearance K243084 · decided 2024-12-27
Clearance details
- K-number
- K243084
- Device name
- BioTraceIO Precision (2.0)
- Applicant
- Techsomed Medical Technologies , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-30
- Decision date
- 2024-12-27
- Days to decision
- 88 days
- Clearance type
- Special
- Product code
- QZL
- Device class
- 2
- Regulation number
- 892.2052
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Rehovot, IL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Techsomed Medical Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BioTraceIO Lite (DEN230020) | Techsomed Medical Technologies , Ltd. | 2023-12-22 |
Recalls involving this device
No recalls on record reference this clearance.