BladderScan Prime PLUS System

by Verathon  · Based in United States → — Insight That Drives Clinical Confidence
Internal Medicine Pediatrics Urology
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Variable
Regulatory Status Disclosed

Overview

The BladderScan Prime PLUS System from Verathon Incorporated is a portable 3D ultrasound instrument designed for non-invasive measurement of urinary bladder volume. It utilizes advanced ImageSense™ artificial intelligence (AI) and deep learning technology to automatically detect and define bladder location, size, and shape across various patient types and anatomies. This technology aims to provide exceptional accuracy, with measurements of ±7.5% on volumes greater than 100 mL (or ±7.5 mL on volumes less than 100 mL) within a range of 0-999 mL.

The system features a user-friendly, ergonomic interface with a touchscreen display that shows bladder volume, directional aiming with real-time feedback (BladderTraq™), and other indicators. Key usability improvements include one-mode scanning for all patient types (male, female, pediatric), point-and-click operation that minimizes user error, and improved BladderTraq™ aiming assist with visual/color cues. The BladderScan Prime PLUS is built with a durable, medical-grade design, ensuring ease of cleaning and compliance with hospital disinfectant standards. It is intended for use in professional healthcare environments such as hospitals, clinics, and doctors’ offices. The system also offers password-protected patient information and the ability to export patient data, including B-mode images and volume estimations, to a USB drive or SD card. While the BladderScan Prime PLUS was introduced in 2015, it has since been discontinued in most geographies, with the BladderScan i10 being its successor.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • ImageSenseu2122 AI and Deep Learning Technology for automated 3D volume calculation
  • BladderTraqu2122 real-time bladder auto-location and aiming assist
  • One-mode scanning for all patient types (adult and pediatric)
  • Point-and-click ease of use, minimizing user error
  • Enhanced EdgeScan off-center scan alerts
  • Pioneering pubic bone interference indicator
  • Touchscreen display with intuitive graphics
  • Password-protected patient information
  • Durable, medical-grade design and simplified cleaning
  • Data export via USB drive or SD card

Use Cases

  • Measuring post-void residual (PVR) urine volume
  • Assessing suspected urinary retention or catheter blockage
  • Aiding in the investigation of incontinence
  • Supporting bladder training programs
  • Evaluating the effectiveness of drug treatments
  • Helping to reduce and avoid catheter-associated urinary tract infections (CAUTI)

What Physicians Need to Know

DICOM Support & Standards
The system supports EHR Charting and allows for quick transfer of configuration settings. Patient data, including B-mode images and volume estimations, can be exported via USB drive or SD card.
PACS Integration Method
While direct PACS integration details are not explicitly provided, the system facilitates data transfer through USB/SD card export and supports EHR charting, suggesting compatibility with broader health information systems.
Reading Room Workflow Impact
Designed for a streamlined workflow with 'point and click' use and one-mode scanning for all patient types, minimizing user error and optimizing clinical workflows. It provides time-saving, one-step automated volume results.
AI Model Architecture (deep learning approach)
Powered by ImageSenseu2122 artificial intelligence (AI), a second-generation algorithm that combines clinical data from thousands of scans and tens of thousands of ultrasound images with deep learning technology. It utilizes a deep learning convolutional neural network to automatically calculate 3D bladder volume, detecting and defining bladder location, size, and shape across various patient types and anatomies.
Processing Speed (per study)
The system offers time-saving, one-step automated volume results, indicating a rapid measurement process.
FDA Clearance Pathway (510k/De Novo)
Received 510(k) clearance (K172356) from the FDA on September 15, 2017, determined to be substantially equivalent to a predicate device.
Supported Modalities
The BladderScan Prime PLUS System is a portable 3D ultrasound instrument, supporting Ultrasound (US) modality for bladder volume measurement.
Sensitivity & Specificity Data
Accuracy is ±7.5% on volumes from 100-999 mL and ±7.5mL on volumes from 0-100mL. This represents a significant improvement over previous BladderScan products and comparable devices.
RSNA/ACR Validation
While specific RSNA/ACR validation for AI in complex radiological image interpretation is not mentioned, a prospective, qualitative, performance and usability study was conducted to characterize the deep learning convolutional neural network in a real patient population.
Physician Tip

The BladderScan Prime PLUS, with its ImageSense AI and deep learning, significantly enhances accuracy and ease of use for bladder volume measurement, reducing user error and optimizing workflow. Its 'point and click' operation and one-mode scanning simplify the process for all patient types. This can be particularly beneficial in reducing catheter-associated urinary tract infections (CAUTIs) by providing reliable, non-invasive bladder assessments. The ability to export data to EHRs is a practical feature for documentation.

The system offers data export capabilities via USB and SD card, and supports EHR charting, facilitating integration into existing electronic health record systems. While direct, full DICOM or PACS integration is not explicitly detailed, the focus on streamlined data transfer aims to support efficient clinical workflows and record-keeping.

Details

Category Radiology & Imaging AI
Pricing Variable
DeploymentOn-premise (portable device)
Data ExportUnknown
TrainingUnknown
Compliance
BAA AvailableUnknown
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Internal Medicine, Pediatrics, Urology

Support & Reliability

Training ProvidedUnknown

What the Web Says

The BladderScan Prime PLUS System is a non-invasive 3D ultrasound device designed for measuring bladder volume. It utilizes ImageSense deep learning technology for improved accuracy and offers a streamlined workflow with automated volume results. The system is intended for use in professional healthcare environments and aims to reduce unnecessary catheterizations and improve patient care.

Overall: Positive

Strengths

  • Improved bladder volume measurement accuracy due to ImageSense deep learning technology.
  • Time-saving, one-step automated volume results.
  • User-friendly interface with a color LCD touchscreen and intuitive graphics.
  • Non-invasive, reducing risks associated with unnecessary catheterization.
  • No sonographer required for operation.
  • Durable design with protection against moisture spills and long-lasting, replaceable batteries.

Limitations

  • Probes can be expensive to repair outside of warranty, especially if dropped.
  • Verathon customer service can be inconsistent, varying by region.
  • Some hospitals prefer competitor products like Medline Biocon-750 due to better customer service.

Based on reviews from: Soma Technology, Artificial Intelligence in Translational Medicine - MDPI, Artificial Intelligence in Translational Medicine | Encyclopedia MDPI, Artificial Intelligence in Translational Medicine - Semantic Scholar, The Ultimate Comparison: Verathon, Butterfly iQ+, and BladGou00ae Bladder Scanners, Paracor Medical, TECHNOPATH, Canada.ca, FDA-cleared listings - Radiology AI Tools Directory, Reddit, Dataintelo, accessdata.fda.gov, BLADDERSCAN PRIME PLUS - Verathon, PicClick, Summary Basis of Decision - BladderScan Prime Plus System - Health Canada

Last updated: 2026-07-20

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Press & Coverage

Health Canada
Summary Basis of Decision - BladderScan Prime Plus System - Health Canada
This document provides a summary of Health Canada's decision to issue a Class III licence to Verathon Inc. for the BladderScan Prime Plus system on April 23, 2019, based on submitted data from quality, preclinical, and clinical studies.
2021-07
FDA
K172356 - 510(k) Premarket Notification - FDA
This FDA 510(k) Premarket Notification details the clearance of the BladderScan Prime PLUS System by Verathon Incorporated on September 15, 2017.
2017-09
Canada.ca
What's new: Medical devices - Canada.ca
This page from Canada.ca lists updates regarding medical devices, including the Summary Basis of Decision (SBD) for the BladderScan Prime Plus System from September 20, 2019.
2026-04
MDPI
Artificial Intelligence in Translational Medicine - MDPI
This peer-reviewed article discusses the application of artificial intelligence in translational medicine and mentions the BladderScan Prime PLUS System as a device utilizing deep learning for improved bladder volume measurement accuracy.
2021-11
Encyclopedia MDPI
Artificial Intelligence in Translational Medicine | Encyclopedia MDPI
This encyclopedia entry highlights the BladderScan Prime PLUS System as an example of a medical device leveraging deep learning for enhanced bladder volume measurement accuracy.
2021-12
accessdata.fda.gov
Butterfly Network, Inc. June 11, 2020 Mr. Brian Sawin Sr. Regulatory Affairs Manager 530 Old Whitfield Street GUILFORD CT 0 - accessdata.fda.gov
This FDA document, dated June 11, 2020, references the BladderScan Prime PLUS System (K172356) from Verathon, Inc. as a predicate device for the Butterfly Auto 3D Bladder Volume Tool, noting its use of machine learning-based algorithms.
2020-06
J-Stage
Future trends in AI (artificial intelligence) technology in clinical lab testing - J-Stage
This article on future trends in AI technology in clinical lab testing lists the BladderScan Prime PLUS System by Verathon Incorporated as an ultrasound device intended for non-invasive bladder urine volume measurement.
2026-01
DOTmed
Used VERATHON Prime Plus Urological Instrument For Sale - DOTmed Listing #4447880:
This listing on DOTmed advertises a used VERATHON BladderScan Prime Plus System for sale in excellent, patient-ready condition with a 90-day warranty.
2026-07

Videos

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Frequently Asked Questions

The BladderScan Prime PLUS System utilizes ImageSense™ artificial intelligence (AI) and deep learning technology to automatically calculate 3D bladder volume. This technology offers significant accuracy, with a ±7.5% margin for volumes between 100-999 mL and ±7.5 mL for volumes between 0-100 mL. This is an improvement over previous BladderScan products. While the AI enhances accuracy and streamlines workflow by eliminating manual probe fanning, physicians should be aware that the ultimate responsibility for clinical outcomes remains with them, and understanding the AI's metrics is crucial, even with its 'black box' nature.
The BladderScan Prime PLUS System is a medical device restricted by Federal (United States) law to sale by or on the order of a physician. It has received a Class III licence from Health Canada. The system's design is medical-grade and compliant with hospital disinfectant standards. While the AI automates tasks and augments decision-making, regulations emphasize balancing AI autonomy with responsible clinical practice, and physicians are responsible for justifying their choices according to professional standards.
Several alternatives exist for bladder volume measurement. Other Verathon models include the BladderScan i10, which also uses ImageSense™ AI and BladderTraq™ technology, and the more portable BladderScan BVI 6100. Other brands offer devices like the Butterfly iQ+ Bladder Scanner and the Medline BioCon 750 Bladder Scanner. When choosing an alternative, factors like accuracy, portability, scanning technology, data management, and cost should be considered.
The price for a BladderScan Prime PLUS System can range from approximately $380 to $4500, depending on whether it's new, used, or refurbished. For example, a refurbished unit with a probe and a one-year warranty might be around $13,675.00. Refurbished options are available from various medical equipment suppliers.
While the BladderScan Prime PLUS System's ImageSense™ AI offers high accuracy and ease of use, radiologists should be aware of potential limitations. The 'black box phenomenon' of some AI systems can raise concerns about interpreting and using results, even with knowledge of data dynamics and metrics. There's also a risk of automation bias, where machine-generated diagnoses might be prioritized over human judgment, potentially leading to errors. The system's accuracy specifications assume it's used according to manufacturer instructions and when scanning a tissue-equivalent phantom.
The BladderScan Prime PLUS System console features two USB ports and an SD card slot, allowing for the export of patient data, including B-mode images and volume estimations, to external, removable media storage devices. It also has a customizable saved scans function to recall, print, and transfer saved exams. Access to saved patient data and exam results can be restricted with a user-defined security code. While it supports data export, specific details on direct integration with broader hospital IT or PACS systems would require further inquiry with the manufacturer.
The BladderScan Prime PLUS System is designed for ease of use and does not require a sonographer for operation. Its ImageSense™ AI and VMode® automated 3D volume acquisition, combined with 'point and click' functionality, minimize user error and optimize clinical workflows, making it accessible to a wide range of clinical users. The system also includes an onboard tutorial and integrated help screen for guidance.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-19 | First Added: 2026-04-19
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