OQTClass II
Prostate Lesion, Documentation, System
Gastroenterology, Urology · 21 CFR 876.2050
Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination.
MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances1All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
1 clearances for this product code