Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound— 510(k) K160792

Substantially Equivalent

The Prometheus Group

FDA 510(k) clearance K160792 for Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound, Substantially Equivalent on 2016-04-15. Applicant: The Prometheus Group.

Clearance details

Applicant: The Prometheus Group
Product code: Code IYO
Advisory panel: Radiology
Date received: 2016-03-23
Decision date: 2016-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.