510(k) DEN230020
- Device
- BioTraceIO Lite
- Applicant
- Techsomed Medical Technologies , Ltd.
- 510(k) number
- DEN230020
- Product code
- QZL
- Decision
- Unknown (DENG)
- Decision date
- 2023-12-22
- Date received
- 2023-03-30
- Regulation
- 892.2052
- Classification name
- Post-Ablation Tissue Response Prediction Software
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- 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
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QZL
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243084 | BioTraceIO Precision (2.0) | Techsomed Medical Technologies , Ltd. | 2024-12-27 |