OPTClass II
Infrared Hematoma Detector
Ophthalmic · 21 CFR 882.1935
To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
MDR events2All time
Recalls1All time
Registered firms5Currently listed
510(k) clearances5All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Injury2
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
5 firms currently registered for this product code
510(k) clearances
5 clearances for this product code