Data / Medical devices / Israel / Brainlab Ltd.
Brainlab Ltd.: FDA-registered device maker in PETACH-TIKVA Central, Israel, 4 510(k) clearances
Brainlab Ltd. is registered with the FDA (registration 3005225421) in PETACH-TIKVA Central, Israel. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 4, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005225421
- Address
- 35 Efal Street, PETACH-TIKVA Central, Israel, 4951132
- Owner or operator
- Brainlab Ltd. (9074705)
- Roles
- Manufacturer
- First device listed
- September 21, 2015
- Registered through
- 2027
- Brand names listed
- TraumaCAD, TraumaCad Mobile 2, TraumaCad Neo, TraumaCad Neo 1.1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 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 |
|---|---|---|---|---|---|---|
| June 4, 2025 | K243810 | TraumaCad Neo (1.1) | QIH | Substantially Equivalent | Brainlab , Ltd. | accessdata.fda.gov |
| November 20, 2023 | K231498 | TraumaCad Neo | LLZ | Substantially Equivalent | Brainlab , Ltd. | accessdata.fda.gov |
| February 12, 2016 | K160001 | TraumaCad Mobile Release 2.0 | LLZ | Substantially Equivalent | Voyant Health, Ltd. | accessdata.fda.gov |
| March 19, 2008 | K073714 | TRAUMACAD VERSION 2.0 | LLZ | Substantially Equivalent | Orthocrat, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
Updated June 4, 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.