Data / Medical devices / Automated Radiological Image Processing Software / Israel
FDA-registered makers of Automated Radiological Image Processing Software in Israel: 13 establishments
13 establishments in Israel are registered with the FDA to make Automated Radiological Image Processing Software (product code QIH). 9 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Automated Radiological Image Processing Software
- Product code
- QIH
- Country
- Israel
Makers of Automated Radiological Image Processing Software in Israel
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Philips Medical Systems Technologies Ltd | Ramat Gan Tel Aviv, Israel | Complaint file establishment, Manufacturer, Specification developer | 10 | March 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Aidoc Medical Ltd. | Tel Aviv-Yafo, Israel | Manufacturer | 3 | November 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Viz.ai Israel Ltd | Tel Aviv, Israel | Manufacturer | 3 | June 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Philips Medical Systems Technologies Ltd. | Haifa, Israel | Complaint file establishment, Exporter to the US, Manufacturer | 2 | January 22, 2026 | 0 | 0 | 0 | api.fda.gov |
| Body Vision Medical Ltd | Netanya Tel Aviv, Israel | Manufacturer | 1 | October 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Brainlab Ltd. | PETACH-TIKVA Central, Israel | Manufacturer | 1 | June 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Orca Dental Ai | Ra'anana Central, Israel | Complaint file establishment, Manufacturer | 1 | March 5, 2026 | 0 | 0 | 0 | api.fda.gov |
| Spectrum Dynamics Medical Ltd. | Caesarea North Ind. Park Central, Israel | Manufacturer | 1 | December 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ultrasight | Ness Ziona Central, Israel | Manufacturer | 1 | December 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Aisap Ltd | Ramat Gan Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arrow Rapac Ltd. | Petach Tikva Central, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems, Israel Ltd. | Haifa, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Techsomed | Or Yehuda Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.