(104 days)
The Direct Digitizer, REGIUS Model 190 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It reads the image recorded on the Plate and transfers the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices. It is designed and intended to be used by trained medical personnel in a clinic, a radiology department in a hospital and in other medical facilities. This device is not intended for use with digital mammography system.
The Direct Digitizer, REGIUS MODEL 190 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette, and reads the image recorded on the Plate by inserting a cassette in the entrance slot of the REGIUS MODEL 190. By means of laser scan and photoelectric method, the device reads the X-ray image data created in form of a latent image on the Plate exposed by an external X-ray generating device, and converts the read data into digital. The signal processing is made to the digital image data such as the digital filtering, the gain-offset correction and the shading collection. Then the REGIUS MODEL 190 is capable of transferring the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices.
The provided text describes the Konica Minolta Medical & Graphic, Inc. Direct Digitizer REGIUS MODEL 190. However, it does not contain information about acceptance criteria, device performance studies, sample sizes for test sets or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.
The document is a 510(k) summary for a medical device that was submitted in 2004 and received a clearance letter correcting a previous one in 2013. It focuses on the device's description, intended use, compliance standards, and substantial equivalence to a predicate device (REGIUS MODEL 170, K023061).
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text. The document primarily serves as regulatory clearance information, not a detailed performance study report.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.