BladderScan Prime PLUS System
Verathon IncorporatedThe BladderScan Prime PLUS System is a non-invasive ultrasound device that measures the volume of urine in the bladder using patented neural network technology. It assists clinicians by providing real-time bladder volume measurements and directional aiming feedback to improve patient management and care.
Intended Use
An ultrasound device intended to be used for measuring urine volume of the bladder non-invasively.
Technology
Uses patented neural network technology for estimating bladder volume from ultrasound images. Employs B-mode ultrasound with a mechanical sector probe at 2.49 MHz / 1.72 MHz. Portable system with real-time feedback on LCD display, battery operation, and no variable acoustic output settings.
Performance
Device passed electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, acoustic output testing, and usability engineering per recognized standards. No new clinical studies were required to support equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/3/2017
1 month - 2
FDA Approval
9/15/2017
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