The !M1 mobile X-ray system by Solutions for tomorrow AB is a diagnostic mobile X-ray system designed to perform general radiography exams on pediatric and adult patients in healthcare facilities. It utilizes digital radiography technology with flat-panel detectors, offering configurations with detectors from manufacturers like Canon, Konica Minolta, and Vieworks, improving image quality and system performance. This helps clinicians obtain diagnostic images efficiently both inside and outside standard X-ray rooms, improving patient care.
Intended Use
The device is designed to perform general radiography x-ray examinations on all pediatric and all adult patients, in all patient treatment areas.
Technology
The !M1 mobile X-ray system consists of a self-contained x-ray generator, flat-panel digital radiography detectors (wireless options available), imaging display, and software for acquiring diagnostic images. It includes upgraded collimators, increased generator power (40 kW, 400 mAs option), and supports detectors from multiple manufacturers with improved pixel size, modulation transfer function (MTF), and detective quantum efficiency (DQE).
Performance
Integration testing of the !M1 system with Vieworks VXvue console and detectors showed successful implementation. The new collimator, upgraded generator (40 kW, 400 mAs), and X-ray tube (133 kV) passed verification and complied with applicable standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/5/2024
10 months - 2
FDA Approval
5/6/2025
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