FDA applicant
Elscint Mr, Inc.
FDA records 3 decisions for Elscint Mr, Inc. (Fort Collins, CO) from 1996 to 1997: 3 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 2 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 Elscint Mr, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Elscint Mr, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Elscint Mr, Inc.’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) ReportOther applicant names beginning “Elscint”
FDA records each applicant name separately; these may or may not be the same firm.