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K Number
K083048
Device Name
NEORAY DR 2520 DIGITAL IMAGING SYSTEM
Manufacturer
PORTAVISION MEDICAL LLC
Date Cleared
2008-11-21

(38 days)

Product Code
IZL
Regulation Number
892.1720
Type
Traditional
Panel
RA
Reference & Predicate Devices
K043062,K973833
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The NeoRay DDR 2520 Digital Imaging System is intended for use in generating radiographic images of human anatomy, it is specifically optimized to operate within the Neonatal environment. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.

Device Description

The NeoRay DDR 2520 Digital Imaging System is a portable X-Ray system comprised of a portable digital radiographic imaging system, an X-Ray generator/collimator system, and a mobile stand.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets them. Instead, it is a 510(k) summary for the NeoRay DDR 2520 Digital Imaging System, describing its intended use, technological characteristics, and substantial equivalence to predicate devices.

The document states:

  • "There are no significant differences between the NeoRay DDR 2520 Digital Imaging System and the predicate devices and therefore, the NeoRay DDR 2520 Digital Imaging System does not raise any questions regarding safety and effectiveness."
  • "The NeoRay DDR 2520 Digital Imaging System, as designed, is as safe and effective as the predicate device, and the device is determined to be substantially equivalent to the referenced predicate device currently on the market."
  • The "technological characteristics between the predicate and proposed devices are identical. There is no difference in fundamental scientific technology. The only difference is the size."

This indicates that the device's acceptance was based on showing substantial equivalence to existing, legally marketed devices, rather than through a performance study against specific acceptance criteria for a new type of functionality. Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not available in this type of submission.

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.