Search Results

The MCA-601, C-Arm Mobile is used for providing fluoroscopic and radiographic images of patient anatomy, especially during special procedures in a hospital or medical clinics. The fluoroscopic mode of operation is very useful to the attending physician to see the images in real time without the need to develop individual films.

High frequency X-ray generator and Image intensifier systems are mounted on C-arm transport mobile base.

The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary for a C-Arm Mobile Fluoroscopic System, indicating a name change for an existing device and its intended use. It largely comprises administrative details, such as company information, device classification, and a letter from the FDA confirming substantial equivalence to legally marketed predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance from the provided text.

Ask a specific question about this device