REC-DI-US-0002-CC - Micro-Ultrasound System

The Coordinating Entity requires a Product that meets or exceeds the following requirements:

High-Frequency Imaging Requirement (29–37 MHz)
The required ultrasound system must support a center frequency between 29 MHz and 37 MHz to enable exceptionally high-resolution imaging of superficial structures.

Dual-Purpose Probe Compatibility (Transperineal and Transrectal Use)
The ultrasound system must support a versatile probe design that allows clinicians to use the same or compatible transducers for both: 
ransperineal prostate biopsies, which require specific spatial orientation, ergonomic guidance channels, and needle template support, and
Transrectal biopsies, which demand probe curvature and field of view suitable for intrarectal placement and navigation.
Very few manufacturers offer probes that can be used interchangeably or have multi-functional transducers certified for both procedural types without requiring two separate systems or probe sets.