Data / Medical devices / Israel / Techsomed
Techsomed: FDA-registered device maker in Or Yehuda Central, Israel, 2 510(k) clearances
Techsomed is registered with the FDA (registration 3030089065) in Or Yehuda Central, Israel. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 8, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030089065
- Address
- 6 Ofra Haza St., Or Yehuda Central, Israel, 6032303
- Owner or operator
- Techsomed (10089374)
- Roles
- Manufacturer
- First device listed
- April 10, 2025
- Registered through
- 2026
- Brand names listed
- BioTraceIO 360, BioTraceIO Precision, BioTraceIO Vision
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Post-Ablation Tissue Response Prediction Software | QZL | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | QTZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2025 | K251931 | BioTraceIO Vision (V1.7) | QTZ | Substantially Equivalent | Techsomed Medical Technologies | accessdata.fda.gov |
| December 27, 2024 | K243084 | BioTraceIO Precision (2.0) | QZL | Substantially Equivalent | Techsomed Medical Technologies , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Device Data System
- All makers of Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
Updated September 8, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.