FDA applicant
Humanscan Company, Ltd.
FDA records 1 decision for Humanscan Company, Ltd. (San Leandro, CA) in 2009: 1 510(k) clearance. All are in product code ITX (Transducer, Ultrasonic, Diagnostic). 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 Humanscan Company, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2009
2009high 1 (2009) · low 0 (2010)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like Humanscan Company, 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