REMEX Xcam6
REMEDI Inc.The REMEX Xcam6 is a portable, handheld mobile X-ray system designed for hospital or clinic use to capture diagnostic X-ray images of patient extremities. It can be used with a flat panel detector to acquire, display, and manipulate images. It enables clinicians to obtain high-quality radiographic images conveniently and safely, aiding the diagnosis of various conditions affecting extremities.
Intended Use
Portable X-ray Equipment REMEX Xcam6 is intended to be used in a hospital or clinic setting under the supervision of a qualified and trained clinician. This product is used as an x-ray source to produce diagnostic x-ray images of patient's extremities using an X-ray detector. It may be used in handheld or stand-mounted configurations for acquiring diagnostic radiographic images of extremities. The device is not intended for mammography. The REMEX Xcam6 is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
Technology
REMEX Xcam6 is a handheld and portable general-purpose X-ray system intended to obtain diagnostic radiographic images of patient’s extremities. It serves as an X-ray source designed to be used with a Flat Panel Detector (FPD). It operates with adjustable tube voltage (40-90 kVp), tube current (2-6 mA), and exposure time (0.06-2.00 sec). The system is battery-powered, enclosed within a handheld unit, and controlled by clinicians to produce diagnostic images.
Performance
The device underwent electrical safety and electromagnetic compatibility testing, image quality and dosimetry bench tests, software verification and validation according to IEC standards, and limited clinical testing. Clinical images of body extremities were reviewed by a board-certified radiologist confirming suitability for diagnosis. These tests demonstrated that REMEX Xcam6 is as safe and effective as the predicate device and performs as intended.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/28/2025
5 months - 2
FDA Approval
7/31/2025
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