Skip to content

BladderScan Prime System

by Verathon Incorporated

510(k) K153101

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK153101 Date19 Nov 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BladderScan Prime System is a 3D ultrasound system that noninvasively measures bladder volume. It consists of a console with a touchscreen display, a probe containing the ultrasound transducer, and a battery charger with rechargeable lithium-ion batteries.

The system is supplied as a reusable device intended for use in clinical settings. It requires maintenance of a minimum distance from portable and mobile RF communications equipment to prevent electromagnetic interference, as specified in the operation and maintenance manual. The device received FDA 510(k) clearance under K153101 and is classified under product code IYO.

Other devices from Verathon Incorporated

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the BladderScan Prime System used for?

    The BladderScan Prime System is used to noninvasively measure bladder volume using 3D ultrasound technology, providing a clinical tool for assessing urinary retention or post-void residual volume without catheterization.

  • Is the BladderScan Prime System reusable or single-use?

    The BladderScan Prime System is supplied as a reusable device intended for use in clinical settings, meaning the console, probe, and battery charger are designed for repeated use with proper cleaning and maintenance between patients.

  • What components are included with the BladderScan Prime System?

    The system consists of a console with a touchscreen display, a probe containing the ultrasound transducer, and a battery charger with rechargeable lithium-ion batteries, all supplied together as a complete unit for clinical operation.

  • Does the BladderScan Prime System require special handling to avoid interference?

    Yes, the system requires maintaining a minimum distance from portable and mobile RF communications equipment to prevent electromagnetic interference, as detailed in the operation and maintenance manual to ensure safe and accurate performance.