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These Portable Diagnostic Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography).

DRAGON X SPSL4HC and DRAGON X SPSL8HC are mobile x-ray units that cover all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These line operated units combine stand-alone feature for exposures for ease in imaging. Two different models of digital image acquisition panels are offered: FDX3543RP and FDX3543RPW. Both of the Toshiba panels and the associated software have been previously cleared by FDA (K130883). Integration with the portable system was straightforward. The device complies with the US Federal Safety Performance Standard and is UL listed.

This document describes the Predicate Device Summary and not a study to prove that the device meets acceptance criteria. The requested information cannot be extracted from the provided text.

Here is a breakdown of why this information cannot be extracted from the provided text:

• No Acceptance Criteria or Performance Data: The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain a pre-defined set of acceptance criteria for the new device's performance, nor does it present data showing the new device's performance against such criteria.
• No Clinical Study Design Details: The document explicitly states "Summary of Clinical Testing: Not required because the proposed digital panels have prior FDA clearance." This means no new clinical study was conducted for this 510(k) submission to assess the device's clinical performance. Therefore, details like sample size, data provenance, expert qualifications, ground truth establishment, MRMC study results, or standalone performance are not present.
• Focus on Substantial Equivalence: The primary objective of this 510(k) is to demonstrate that the DRAGON X SPSL4HC and DRAGON X SPSL8HC are substantially equivalent to the predicate device (Sedecal Digital Portable X-ray Units: SPSLW4 and SPSLW8). This is achieved by comparing characteristics like intended use, configuration, performance standards, generator, collimator, and power source, and noting that the only key difference is the manufacturer of the digital panel and accompanying software, which themselves have prior FDA clearance (K130883).
• Bench and Lab Testing Summary: While Section 7 mentions "Laboratory testing included performance testing to the DHHS Radiation Safety Performance Standard, Electrical Safety per IEC-60601. EMC per IEC-60601-1-2; IEC 60601-1-3 Radiation protection in diagnostic X-ray equipment, IEC 60601-2-54 Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment for Radiography and Radioscopy, and FCC Parts 15 and 18. A risk analysis was performed. Test images were obtained to confirm total system functionality. Every unit manufactured undergoes thorough performance testing which includes visual and configuration testing, hipot testing, generator testing, including generator controls (voltage, current, timing), and image acquisition," these are general statements about compliance with regulatory standards and functional checks, not a detailed study with specific acceptance criteria and quantitative results for clinical or algorithmic performance as requested.

In summary, this document is a regulatory submission demonstrating substantial equivalence, not a research paper detailing a study of acceptance criteria and device performance.

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