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The B6 is a mobile digital X-ray diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes:real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery. It is not intended to be used in interventional procedures. The B6 permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients.

There are two sets of X-ray tube assemblies and Image Intensifiers which are perpendicularly distributed on the G-Arm, acting as two sets of vertical X-ray source and receptor systems and providing fluoroscopy image of the patient. The two sets of X-ray tube assemblies and Image Intensifiers can operate simultaneously and separately. The B6 is comprised of control unit and G-Arm, the control unit and G-Arm include below primary components. Control Unit Major Component | Qty. ------------------------------|------ Viewing monitor | 2 Control monitor | 1 Keyboard | 1 Footswitch (3- or 2- pedal) | 1 Printer(optional) | 1 G-Arm Major Component | Qty. ----------------------------|------ Image intensifier assembly | 2 X-Ray tube assembly | 2 Laser light indicator | 2 The G-Arm system offers a group of motor-driven positioning features, including: - lmage Intensifier Adjustment: 300 mm±10mm - G-Arm Height Adjustment: 300 mm±10mm - G-Arm Orbital Rotation: +35°+2° - G-Arm Radial Rotation: ±45°±2° The B6 can be operated in two different modes: Continuous fluoroscopy and Pulse fluoroscopy. Each of these two modes can be operated either manually or automatically. So, the fluoroscopy mode can be categorized by the X-ray emitting pattern or by the control method of the imaging process, which consequently divides a fluoroscopy mode into the following four major types: Automatic Continuous Fluoroscopy, Automatic Pulse Fluoroscopy, Manual Pulse Fluoroscopy, Manual Continuous Fluoroscopy. Besides the above four fundamental fluoroscopy modes, the G-Arm system offers two other features: ER Fluoroscopy and Half Dose Fluoroscopy (modifies only Automatic Pulse Fluoroscopy and Automatic Continuous Fluoroscopy modes)

The DigiArc 100AU/ DigiArc 100AU+ is a mobile digital X-ray G-Arm diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures. The DigiArc 100AU/ DigiArc 100AU+ permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients at the age of at least eighteen.

The DigiArc 100AU/ DigiArc 100AU+ is a mobile digital X-ray G-Arm diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures. There are two sets of X-ray tube assemblies and Image Intensifiers which are perpendicularly distributed on the G-Arm, acting as two sets of vertical X-ray source and receptor systems and providing fluoroscopy image of the patient. The two sets of X-ray tube assemblies and Image Intensifiers can operate simultaneously and separately.

The current modifications do not change the indications for use. As previously reported and cleared: the DigiArc 100AU+ is a mobile digital X-ray G-Arm diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures. The DigiArc 100AU+ permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients at the age of at least eighteen.

The DigiArc 100AU+ is a mobile digital X-ray G-Arm diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures. There are two sets of X-ray tube assemblies and Image Intensifiers which are perpendicularly distributed on the G-Arm, acting as two sets of vertical X-ray source and receptor systems and providing fluoroscopy image of the patient. The two sets of X-ray tube assemblies and Image Intensifiers can operate simultaneously and separately. The DigiArc 100AU+ includes below primary components. Control unit Viewing monitor Control monitor Control panel G-Arm Image intensifier assembly X-ray tube assembly Foot switch subassembly Laser aimer system Tracking wheel system Printer (optional): thermal or laser printer