(78 days)
DicomNet is intended to be used for storing and displaying digital images acquired and stored by digital imaging systems on DICOM interchange media. DicomNet reviews images directly from the DICOM storage media (CD-Recordable disks) and can store the images in an archive manager for review on any of the network review stations. The system stores unaltered/uncompressed computer digital data.
DicomNet is composed of the following: Cardiac Review Station, Archive Manager, DLT Drive, Automatic Tape Library, RAID, ATM Switch.
The provided text describes the DicomNet device, its components, indications for use, and a comparison to a predicate device (GEMnet). However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot answer your specific questions as outlined in the prompt. The document primarily focuses on the device's description and its substantial equivalence to a predicate device, rather than performance metrics or a formal study.
To answer your questions, I would need a document that includes:
- Specific performance metrics (e.g., accuracy, sensitivity, specificity, processing speed, image quality standards).
- Defined acceptance criteria for these metrics.
- Details of a study conducted to evaluate these metrics against the acceptance criteria.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.