Optical Tracking System (OTS)

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

510(k) Number

K990632 ↗

FDA Product Code

HAW

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Radionics, Inc. →

• What types of surgical procedures is the Optical Tracking System (OTS) primarily designed to assist with, and how does it work during those procedures?

  The Optical Tracking System (OTS) is designed for intraoperative navigation, particularly in neurology applications, where precise spatial orientation is critical. It uses optical sensors and tracking markers to provide real-time visualization and guidance during surgery. By tracking the position of surgical instruments and anatomical landmarks, the OTS helps surgeons maintain accuracy and alignment, reducing the risk of error in procedures where millimeter precision matters.

• Is the Optical Tracking System (OTS) intended for single-use or reusable applications, and what does that mean for maintenance and upkeep?

  The OTS is classified as a reusable device, meaning it is designed to be used multiple times after proper cleaning, disinfection, and maintenance. Since it is not sterile by default, facilities must follow established protocols for reprocessing to ensure safety and functionality between uses. This includes regular calibration checks, as optical tracking systems can be sensitive to environmental factors like dust or misalignment.

• What hardware and software components does the OTS include, and how is it typically deployed in an operating room?

  The OTS is supplied as a hardware-software combination, meaning it includes both physical tracking equipment (such as cameras, sensors, and markers) and accompanying software for navigation and visualization. It is designed for use in operating rooms where intraoperative guidance is required. The system requires proper setup, including mounting tracking cameras and attaching markers to surgical instruments or patient anatomy, to enable real-time spatial tracking during procedures.

• Are there any specific storage requirements for the Optical Tracking System (OTS) to ensure its longevity and performance?

  While the provided data does not specify exact storage conditions, reusable medical devices like the OTS generally require protection from environmental contaminants (e.g., dust, moisture) and physical damage. Facilities should store the system in a clean, dry environment when not in use, following manufacturer guidelines for maintenance to preserve optical clarity and calibration accuracy. Proper handling and storage help extend the device’s operational lifespan.