FDA applicant
Insightech, Ltd.
FDA records 1 decision for Insightech, Ltd. (Tirat Carmel, IL) in 2011: 1 510(k) clearance. All are in product code MOS (Coil, Magnetic Resonance, Specialty). 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 Insightech, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2011high 1 (2011) · low 0 (2012)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Insightech, 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