PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS
Prognosys Medical Systems Private LimitedThe PRORAD ATLAS ULTRAPORTABLE and ULTRAPORTABLE PLUS are portable digital X-ray systems designed to provide high-quality diagnostic images of body extremities. These battery-operated portable X-ray devices use flat-panel detectors and advanced image acquisition software to produce clear, digital radiographs, aiding fast and accurate clinical diagnosis. They are intended for use in varied healthcare settings including field locations and tele-radiology setups, operated by trained medical professionals.
Intended Use
Digital X-ray system intended to deliver high-quality, diagnostic radiographic images of body extremities using a portable X-ray unit, flat-panel detector, and image acquisition software. Intended for use in healthcare centers, emergency sites, outreach and tele-radiology settings by trained medical professionals.
Technology
Battery-powered portable X-ray generator with fixed 70kV and 2mA tube current. Includes adjustable tripoded X-ray tube, flat-panel digital detectors, and wireless data transmission to software for image processing and diagnostic display. Two models differ primarily in exposure time ranges and real-time image processing capabilities.
Performance
Device performance and safety validated through compliance with IEC and ISO standards for medical electrical equipment, radiation protection, usability engineering, software lifecycle, and risk management. Clinical testing included radiologist-reviewed images from diverse patient populations confirming acceptable diagnostic image quality.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/8/2024
8 months - 2
FDA Approval
7/29/2025
Other devices from Prognosys Medical Systems Private Limited
- PRORAD X-Ray Flat Panel Detector with DROC2024 • 510K
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