FDA applicant
Voyant Health, Ltd.
FDA records 2 decisions for Voyant Health, Ltd. (Petach-Tikva, IL) from 2015 to 2016: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 3 predicates, 1 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 Voyant Health, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2015high 1 (2015) · low 0 (2017)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Voyant Health, 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