510(k) K243084
- Device
- BioTraceIO Precision (2.0)
- Applicant
- Techsomed Medical Technologies , Ltd.
- 510(k) number
- K243084
- Product code
- QZL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-27
- Date received
- 2024-09-30
- Regulation
- 892.2052
- Classification name
- Post-Ablation Tissue Response Prediction Software
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Dalia Dickman
- Address
- Meir Weisgal 2 Rehovot IL 7654055 7654055
FDA Registration Numbers
- 3030089065
Source Documents
Other 510(k) Records For Product Code QZL
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN230020 | BioTraceIO Lite | Techsomed Medical Technologies , Ltd. | 2023-12-22 |