Data / Medical devices / Israel / Ultrasight
Ultrasight: FDA-registered device maker in Ness Ziona Central, Israel, 3 510(k) clearances
Ultrasight is registered with the FDA (registration 3029923647) in Ness Ziona Central, Israel. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029923647
- Address
- 8 Pinchas Sapir st., Ness Ziona Central, Israel, 7403631
- Owner or operator
- UltraSight (10088859)
- Roles
- Manufacturer
- First device listed
- October 23, 2023
- Registered through
- 2026
- Brand names listed
- PVAD IQ, UltraSight AI Real Time Guidance, UltraSight Guidance
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Image Acquisition And/Or Optimization Guided By Artificial Intelligence | QJU | 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 |
|---|---|---|---|---|---|---|
| December 18, 2025 | K252235 | PVAD IQ Software | QIH | Substantially Equivalent | Ultrasight , Ltd. | accessdata.fda.gov |
| December 17, 2025 | K251416 | UltraSight Guidance | QJU | Substantially Equivalent | Ultrasight , Ltd. | accessdata.fda.gov |
| July 24, 2023 | K223347 | UltraSight AI Guidance | QJU | Substantially Equivalent | Ultrasight, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Updated December 18, 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.