Voyager Compact Imaging System

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

510(k) Number

K092182 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Voyager Personal Imaging Device

  Class II

  FDA 510(k) K050551 Active Cleared 22 Mar 2005

• Seeker/Spark Ultrasound System

  Class II

  FDA 510(k) K060800 Active Cleared 7 Apr 2006

• What types of imaging modes and features does the Voyager Compact Imaging System support, and how are they clinically useful?

  The Voyager Compact Imaging System supports real-time B-mode and M-mode imaging, which are essential for visualizing internal structures dynamically. B-mode provides cross-sectional images of tissues, ideal for assessing organ shape, size, and pathology, while M-mode offers motion tracking over time, useful for evaluating cardiac function or fetal heart rate. Additionally, it includes non-metrological 3D rendering for enhanced spatial understanding and needle guidance to assist in procedural accuracy, such as biopsies or injections.

• How is the Voyager Compact Imaging System supplied, and does it require any special handling or sterilization?

  The Voyager Compact Imaging System is supplied as a standalone, portable device designed for clinical radiology use. Since it is not classified as single-use or reusable, it does not require sterilization between uses. However, the mechanical sector-scan probes (C4, C10, EC) should be handled with care to avoid damage, and any cleaning should follow manufacturer guidelines to maintain image quality and functionality.

• What are the key probe options available for the Voyager Compact Imaging System, and how do they differ?

  The Voyager Compact Imaging System includes three mechanical sector-scan probes: C4, C10, and EC. These probes differ primarily in their design and intended use—likely corresponding to varying field-of-view sizes or depth capabilities. The C4 and C10 may offer different focal lengths or imaging depths, while the EC probe could be optimized for specific applications like echocardiography or abdominal imaging. The exact specifications for each probe are not detailed, but their mechanical design suggests flexibility for different clinical scenarios.

• Is the Voyager Compact Imaging System suitable for use in environments with MRI machines, and what are the storage requirements?

  The device does not specify MRI safety information, meaning it may not be explicitly approved for use in MRI environments. Clinicians should verify compatibility with their facility’s MRI protocols or consult the manufacturer for guidance. Regarding storage, the system is portable and designed for clinical use, so it should be stored in a clean, dry environment away from extreme temperatures or direct sunlight to preserve functionality and image quality.

• How was the Voyager Compact Imaging System reviewed by the FDA, and what does the clearance indicate about its regulatory status?

  The Voyager Compact Imaging System received FDA clearance through a 510(k) submission (K092182) under the Radiology Advisory Committee, classified as substantially equivalent to a predicate device. The clearance was granted on October 9, 2009, following a traditional review process. This indicates that the FDA determined the device meets the same performance criteria as existing, legally marketed ultrasound systems in its category, ensuring it complies with safety and effectiveness standards for diagnostic ultrasound use.