(90 days)
The IMDIS is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
The IMDIS is comprised of two mobile units: a C-arm stand and a workstation. The C-arm stand supports the high-voltage generator, x-ray controls, and a "C" shaped apparatus which supports an x-ray tube on one end and an image intensifier on the other. The Carm is designed to perform linear and rotational motions which allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The mobile workstation, supports image display monitors, image processing and recording devices.
Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets, and DICOM 3.0. An auxiliary connection is provided for a Medrad angiographic injector system to facilitate synchronized acquisition of angiographic images during contrast media iniection.
I'm sorry, but the provided text does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets them.
The document is a 510(k) summary for the OEC Medical Systems, Inc. Interventional Mobile Digital Imaging System (IMDIS). It includes:
- Device Description: What the IMDIS is and its components.
- Indications For Use: The intended applications of the device.
- Substantial Equivalence: Comparison to already marketed devices (OEC Medical Systems SERIES 9600® and Philips Medical Systems BV 300 Series Mobile C-arm System).
- Standards: A list of product safety requirements and electrical/radiation standards the device is designed in accordance with.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about a specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication method, MRMC studies, standalone performance).
- Information on training set size or how its ground truth was established.
This document mainly focuses on demonstrating that the IMDIS is substantially equivalent to existing devices and complies with relevant safety standards, rather than detailing a performance study with specific acceptance criteria and results for the device itself.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.