FDA applicant
Zebra Medical Vision, Ltd.
FDA records 9 decisions for Zebra Medical Vision, Ltd. (Sefayim, IL) from 2018 to 2021: 9 510(k) clearances. Most are in product codes QFM (Radiological Computer-Assisted Prioritization…) and JAK (System, X-Ray, Tomography, Computed). Since 2016 its 510(k)s took a median of 111 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Zebra Medical Vision, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Zebra Medical Vision, 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