Karl Storz VOICE1 SCB R-UI Speech Control Application

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

510(k) Number

K083598 ↗

FDA Product Code

ODA

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K252624 Active Cleared 15 May 2026

• Ksea Dion-Gracia Set

  Class II

  FDA 510(k) K010785 Active Cleared 21 Aug 2001

• Karl Storz Slotted Whisker Arthroscopic Blade

  Class II

  FDA 510(k) K963029 Active Cleared 27 Nov 1996

• Storz SLX-F2 Storm Touch

  Class II

  FDA 510(k) K070579 Active Cleared 30 Aug 2007

• Karl Storz Micro-Instrument for Cochlear Implantation

  Class I

  FDA 510(k) K946332 Active Cleared 5 Jun 1995

• Flexible Video-Uretero-Renoscope System Open recall

  Class II

  FDA 510(k) K131369 Active Cleared 26 Nov 2013

See all devices from Karl Storz Endoscopy-America, Inc. →

• What is the Karl Storz Voice1 SCB R-UI Speech Control Application used for?

  The Voice1 SCB R-UI Speech Control Application is a software tool designed to enable voice-activated control of Karl Storz-approved endoscopic devices and peripherals. It integrates with the SCB R-UI system to allow clinicians to operate instrumentation hands-free during surgical procedures, improving efficiency in gastroenterology and urology settings. This eliminates the need for manual input, reducing distractions and streamlining workflows.

• How is the Voice1 SCB R-UI Speech Control Application supplied and does it require sterilization?

  The application is supplied as part of the Karl Storz SCB R-UI system and is not a standalone physical device. Since it is a software-based tool that operates externally and does not come into direct contact with patients, it does not require sterilization. It is classified as a reusable software solution, meaning it can be used repeatedly across multiple procedures without disposal.

• Is the Voice1 SCB R-UI Speech Control Application compatible with MRI environments?

  The Voice1 SCB R-UI Speech Control Application is not intended for use in MRI environments. As a software application without metallic or ferromagnetic components, it is neither explicitly labeled as MRI-safe nor MRI-unsafe. However, its design does not involve any hardware that would interact with MRI systems, so it does not pose a direct risk in those settings. Always follow facility-specific MRI safety protocols when integrating software solutions.

• What medical specialties is this application intended for?

  The Voice1 SCB R-UI Speech Control Application is primarily intended for use in gastroenterology and urology procedures. Its voice-activated functionality is particularly beneficial in these specialties, where precise control of endoscopic instrumentation is critical. The application is designed to enhance procedural efficiency by allowing verbal interaction with approved Karl Storz devices, reducing the need for manual adjustments during surgery.

• How does the Voice1 SCB R-UI Speech Control Application achieve hands-free operation?

  The application achieves hands-free operation by integrating with the SCB R-UI system to recognize and execute voice commands. Clinicians can verbally instruct the system to control compatible endoscopic devices and peripherals, such as activating tools, adjusting settings, or navigating instruments—all without physical interaction. This design minimizes interruptions and allows for a more focused surgical environment, particularly during complex procedures where precision and speed are essential.