BioTraceIO Lite
FDA 510(k) clearance DEN230020 · decided 2023-12-22
Clearance details
- K-number
- DEN230020
- Device name
- BioTraceIO Lite
- Applicant
- Techsomed Medical Technologies , Ltd.
- Decision
- Unknown
- Date received
- 2023-03-30
- Decision date
- 2023-12-22
- Days to decision
- 267 days
- Clearance type
- Direct
- 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
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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 |
|---|---|---|
| BioTraceIO Precision (2.0) (K243084) | Techsomed Medical Technologies , Ltd. | 2024-12-27 |
Recalls involving this device
No recalls on record reference this clearance.