BladderScan Prime PLUS System

by Verathon Incorporated  · Based in United States → — AI-Powered Bladder Volume Measurement for Enhanced Accuracy and Workflow
Internal Medicine Pediatrics Urology
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Varies significantly based on condition (new, used, refurbished) and retailer.
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 Varies significantly based on condition (new, used, refurbished) and retailer.
  • New/Like-new: ~$5,999.00 - $10,999.00; Used/Refurbished: ~$380.00 - $1,500.00 (mainframe only) or up to $5,000+
DeploymentPortable, handheld device with optional mobile cart
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status 1 AI-estimated

The BladderScan® PRIME PLUS system received 510(k) premarket notification clearance (K172356) on September 15, 2017, as an ultrasound device intended for non-invasive measurement of urine volume in the bladder.
Integrations
EHR Not specified
Specialties Internal Medicine, Pediatrics, Urology

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

Product demos, reviews, and walkthroughs for BladderScan Prime PLUS System.

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Frequently Asked Questions

The BladderScan Prime PLUS System utilizes ImageSenseu2122 deep learning technology, a second-generation AI algorithm, to automatically calculate 3D bladder volume. This AI analyzes thousands of scans and ultrasound images to precisely detect and define bladder location, size, and shape, which minimizes user error and optimizes clinical workflows.
The system is designed with features like password-protected patient information and the ability to export data to external memory solutions like USB drives or SD cards. It is intended for use in professional healthcare environments and adheres to HIPAA privacy guidelines.
Alternatives include other portable bladder scanners such as the Verathon BladderScan i10, BladGo 2.0, Butterfly iQ+, and various Avantsonic models. Some of these alternatives also incorporate AI or advanced algorithms for bladder volume assessment and improved accuracy.
The pricing for a new BladderScan Prime PLUS System can vary, with some listings around $5,999.00, though prices can range widely depending on the retailer and condition (new, used, or refurbished). While the initial purchase covers the device, there may be additional recurring costs for software updates, AI feature enhancements, or service contracts, and some systems offer onboard software to calculate cost savings from avoided catheterizations.
While the AI (ImageSenseu2122) aims for high accuracy across various patient types, limitations can arise with extreme body habitus, certain anatomical anomalies, or pubic bone interference, which the system attempts to alert the user about. The AI provides decision support and should always be used in conjunction with clinical judgment.
The BladderScan Prime PLUS System offers connectivity options, such as USB and SD card slots, to facilitate the transfer of patient data, including B-mode images and AI-enhanced volume estimations. Verathon's Scan Point image management software can link patients, exams, and EHR systems for viewing, printing, and secure online storage.
The AI algorithms, specifically ImageSenseu2122 deep learning technology, have undergone rigorous testing and validation, combining clinical data from thousands of scans. Studies have shown an accuracy of ±7.5% for volumes from 100-999 mL and ±7.5 mL for volumes from 0-100 mL, representing a significant improvement over previous models.

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