Perception GPS-RST Diagnostic Ultrasound System

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

510(k) Number

K974880 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Perception Inc. Gps-Tuv Diagnostic Ultrasound System

  Class II

  FDA 510(k) K972973 Active Cleared 15 Oct 1997

• Perception Inc, Gps-6TBMD Diagnostic Ultrasound System

  Class II

  FDA 510(k) K981834 Active Cleared 29 Sep 1998

• Perception Inc. Gps-Xyz Diagnostic Ultrasound System

  Class II

  FDA 510(k) K972192 Active Cleared 17 Dec 1997

• What diagnostic capabilities does the Perception GPS-RST Diagnostic Ultrasound System offer?

  The Perception GPS-RST Diagnostic Ultrasound System provides multiple imaging modes for comprehensive diagnostic evaluations. It supports M-mode for motion assessment, B-mode for static anatomical imaging, combined M&B-mode for simultaneous motion and static imaging, Dual B-mode for side-by-side comparisons, Quad B-mode for four-image displays, and Doppler (D and D/B) for blood flow analysis. These modes enable detailed visualization of organs, tissues, and vascular structures in radiology settings.

• How is the Perception GPS-RST Diagnostic Ultrasound System supplied, and what does it include?

  The Perception GPS-RST Diagnostic Ultrasound System is supplied as a complete imaging system. It includes the core ultrasound unit along with compatible mechanical sector and electronic linear array probes, which feature a fluid-filled design for high-resolution imaging. The system is designed for use in radiology departments and requires appropriate clinical training for operation, as it involves specialized imaging techniques.

• Is the Perception GPS-RST Diagnostic Ultrasound System single-use or reusable?

  The available data does not specify whether the Perception GPS-RST Diagnostic Ultrasound System itself or its probes are single-use or reusable. Typically, ultrasound systems like this are reusable, but the probes may require cleaning and maintenance between uses. For precise guidance, refer to the manufacturer’s instructions or facility protocols, as sterility and reuse depend on clinical workflow and infection control practices.

• What regulatory clearance does the Perception GPS-RST Diagnostic Ultrasound System hold?

  The Perception GPS-RST Diagnostic Ultrasound System holds FDA 510(k) clearance under the reference number K974880, issued on June 8, 1998. This clearance indicates that the device meets regulatory standards for pulsed-echo ultrasound systems under product code IYO, classified as Class II with Special Controls. The submission was reviewed by the Radiology (RA) Advisory Committee.

• Are there any special storage or handling requirements for the Perception GPS-RST Diagnostic Ultrasound System?

  The manufacturer does not provide specific storage or handling instructions beyond standard protocols for medical imaging equipment. Generally, ultrasound systems should be stored in a clean, dry environment protected from extreme temperatures and physical damage. Probes should be stored according to manufacturer guidelines to maintain performance and hygiene. Always follow facility-specific infection control and maintenance procedures.