ULTRA 1040
ECORAY Co., Ltd.The ULTRA 1040 is a portable X-ray device designed for use by trained physicians or technicians to capture X-ray images of patients' extremities. It allows for flexible diagnostic imaging outside traditional settings, helping clinicians assess bone and joint conditions conveniently. It supports use with an X-ray detector and image processing software for image acquisition and processing.
Intended Use
The ULTRA 1040 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the patient’s extremities. This device is not intended for mammography.
Technology
The device consists of an X-ray main unit which emits X-rays, an exposure hand switch for output control, and a battery charger. It operates with an X-ray detector and computer/software for signal detection and image processing. The system control software manages real-time interaction, controls high-voltage generation for X-ray emission, collimator switching, status monitoring, and user interface functions.
Performance
The device underwent performance testing including electrical safety, EMC, software validation, and battery performance. Bench testing assessed radiation performance, collimator accuracy, imaging quality, and safety, which met acceptance criteria, supporting substantial equivalence to predicate devices. Clinical image quality studies confirmed imaging adequacy for the intended anatomical regions.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/9/2024
9 months - 2
FDA Approval
4/18/2025
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