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The 9900 Plus Mobile Fluoroscopy System is designed to provide fluoroscopic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The digital fluoroscopic imaging systems are intended to replace fluoroscopic system images obtained through image intensifier technology.

The 9900 Plus 3D option is a software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. 9900 Pins 3D is intended for imaging bone and soft tissues as well as other internal body structures. 9900 Plus 3D is not intended for mammography applications.

The surgical Navigation feature is intended as an aid to the surgeon for locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from through of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone or vertebra visible on fluoroscopic images. The system may be used for other imaging applications at the physicians discretion.

The GE OEC 9900 Plus is a digital image intensified fluoroscopic mobile C-arm system. It consists of a C-arm that supports a high-voltage generator, X-ray tube, X-ray controls, flatpanel digital detector, and LCD monitors. The C-arm is designed to perform linear and rotational motions that allow the user to position the X-ray imaging components at various angles and distances with respect to the patient. The GE OEC Workstation is a mobile platform that provides image display screens, image processing, recording, and problem devices.

Interfaces are provided for optional peripheral devices such as thermal or laser printer, video recording devices, and display monitors. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets, and DIC WM . An auxillary connection is provided for an angiographic injector system to facilitate synchronization of angiographic images during contrast media injections.

This document is a 510(k) summary for the GE OEC 9900 Plus Mobile Digital C-Arm. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document outlines:

• Submitter Information: GE OEC Medical Systems, Inc.
• Device Proprietary Name: GE OEC 9900 Plus
• Classification Name: Image Intensified Fluoroscopic X-ray System with Image Processing System / Mobile X-ray system.
• Common/Usual Names: Fluoroscopic Imaging System or Mobile C-arm.
• Substantial Equivalence: To the GE OEC 9900 Elite Mobile C-Arm (K041932) and GE OEC 9900 Elite™ Mobile C-Arm (K041931).
• Indications for Use: Provides fluoroscopic images of human anatomy during diagnostic, surgical, and interventional procedures. Specific applications listed include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care, and emergency room procedures. It also mentions a 3D option for reconstructing 3D volumes from Rotational Fluoroscopy and a surgical navigation feature to aid in locating anatomical structures.
• General Description: A digital image intensified fluoroscopic mobile C-arm system with a C-arm, high-voltage generator, X-ray tube, X-ray controls, flat-panel digital detector, LCD monitors, and a mobile workstation for image display, processing, and recording.

The FDA's letter (K061953) acknowledges the substantial equivalence determination but does not include details on performance criteria or validation studies beyond the general statement of substantial equivalence to predicate devices.

Therefore, I cannot provide the requested table or information regarding acceptance criteria and studies, as this specific document does not contain that level of detail. The FDA's 510(k) clearance process is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies against specific acceptance criteria for every new submission, especially for established device types like C-arms.

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