FDA applicant
Ultrasight, Ltd.
FDA records 3 decisions for Ultrasight, Ltd. (Ness Ziona, IL) from 2023 to 2025: 3 510(k) clearances. Most are in product codes QJU (Image Acquisition And/Or Optimization Guided…) and QIH (Automated Radiological Image Processing Software). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Ultrasight, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ultrasight, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Ultrasight, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report