(64 days)
The Digital Imager software is used to acquire and store image or patient data. This data can then be transmitted, stored and viewed over a computer network or off-site using an internet connection. Typical users of this system are trained professionals, including but not limited to physicians, technicians and nurses.
Digital Imager software is used to acquire and store image or patient data. This data can then be transmitted, stored and viewed over a computer network or off-site using an internet connection.
The provided text is a 510(k) premarket notification letter from the FDA to Pyramid Medical, Inc. regarding their "Digital Imager" device. It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria, study details, device performance, sample sizes, ground truth establishment, or expert qualifications. The letter is an approval notification, not a technical report or scientific study summary.
Therefore, I cannot answer the questions based on the provided input.
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.