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The Series 9600 Mobile Digital Imaging System 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 Series 9600 system is comprised of two mobile units: the C-arm unit supports the high-voltage generator, x-ray components and x-ray controls; and the other unit, a mobile workstation, supports image display monitors, image processing and recording devices. The C-arm includes a "C" shaped arm that 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.

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.

This document is a 510(k) summary for the OEC Medical Systems Series 9600 Mobile Digital Imaging System (modified - Phase III). It focuses on establishing substantial equivalence with existing devices rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, the provided text does not contain the information required to populate the table and answer the questions about acceptance criteria and a study proving the device meets those criteria.

The document details:

• The device's proprietary and classification names.
• Indications for use and user characteristics.
• A general description of the system.
• The standards the device complies with (e.g., FDA Federal Performance Standard for Diagnostic X-ray Systems, ANSI/NFPA, UL, CSA, IEC standards related to electrical safety and radiation protection).

However, it does not include:

• A set of quantitative acceptance criteria for image quality, diagnostic accuracy, or any other performance metric.
• A study design, methodology, or results demonstrating the device's performance against such criteria.
• Information about training/test set sample sizes, data provenance, ground truth establishment, expert qualifications, or MRMC studies.

The purpose of this 510(k) summary is to demonstrate that the modified Series 9600 is substantially equivalent to legally marketed predicate devices, not to prove its performance against novel acceptance criteria through a specific clinical or technical study.

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