Digital Radiography System (ManntiX B, ManntiX K)
Shenzhen Browiner Tech Co., LtdThe Digital Radiography System (ManntiX B, ManntiX K) by Shenzhen Browiner Tech Co., Ltd is a portable digital X-ray system designed to acquire high-quality X-ray images of various parts of the patient's anatomy including head, spine, chest, abdomen, pelvis, and extremities. It supports different digital detectors and image processing systems to assist clinicians in obtaining and viewing diagnostic images conveniently. It helps physicians and technicians capture diagnostic X-ray images efficiently in diverse clinical settings.
Intended Use
Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). This device is not intended for mammography and pediatric patients.
Technology
The system consists of major components including a portable X-ray assembly with collimator and tube, X-ray protective device, mobile stand, digital detectors (models CareView 1500Cwe, Mars1717X, Luna 1012X), image processing system, and image acquisition workstation. The X-ray generator operates up to 125kVp with various tube current and exposure settings. The digital detectors convert X-rays to visible and electrical signals that are digitized and processed to generate images. Communication supports wired and wireless modes. The system is compatible with DICOM 3.0 and designed with IEC standards compliance.
Performance
The device has undergone extensive non-clinical performance testing including electrical safety and essential performance under IEC 60601 series standards, radiation protection assessments, software lifecycle processes per IEC 62304, usability engineering under IEC 62366-1, and biocompatibility testing per ISO 10993-1 standards. Non-clinical testing demonstrated substantial equivalency to a predicate device and no new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/27/2024
8 months - 2
FDA Approval
12/9/2024
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