FDA applicant
Ibm Israel, Ltd.
FDA records 1 decision for Ibm Israel, Ltd. (Efrat, IL) in 1999: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 0 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 Ibm Israel, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ibm Israel, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ibm Israel, 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