(66 days)
Agfa's Computed Radiography Systems with NX Workstations are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.
Systems can be used with either Musica or Musica ? image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
System options and accessories are available for:
- . Pediatric imaging
- . Full leg/full spine
- Radiotherapy planning and QC ●
- Musica2 Platinum (thorax, abdomen or musculoskeletal regions of adult or . pediatric patients)
- Musica2 Neonatal .
Agfa's Computed Radiography Systems with NX Workstations are not indicated for use in mammography.
The predicate and new devices are nearly identical computed radiography imaging systems. New NX workstations provide the following benefits:
- The capability of presenting images on other computers configured with the Office Viewer application.
- Musica2 image processing for Neonatal images. ●
- . Improved Musica2 Platinum image processing for pediatric skeletal images.
- An Export/import tool to support future upgrades. .
- A dedicated Intensive Care Unit (ICU) work-flow. ●
The principles of operation of the new and predicate devices are the same. They have the same underlying technological characteristics.
The provided text is a 510(k) summary for Agfa's Computed Radiography (CR) Systems with NX Workstations. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about a study to prove device performance against specific acceptance criteria in the comprehensive manner requested.
Specifically, the document states:
- "Agfa's Computed Radiography (CR) Systems with NX Workstations have been tested for proper performance to specifications through various internal tests."
- "Components have been tested and shown to meet the requirements of EN 60601-1-1 and EN 60601-1-2."
These statements indicate that testing occurred, but they do not provide the detailed information requested regarding acceptance criteria, reported performance values, study design (sample sizes, expert involvement, adjudication, etc.), or specific ground truth methodologies for image quality or diagnostic performance. The focus of this 510(k) is on the similarity of the new device to an existing predicate and the addition of new features, rather than a de novo clinical performance study with predefined acceptance criteria for diagnostic efficacy.
Therefore, the requested table and detailed information cannot be extracted from the provided text because such a detailed performance study, with the specific elements outlined in the prompt, is not included within this 510(k) submission. 510(k) submissions often rely on bench testing and comparisons to predicate devices for substantial equivalence, rather than extensive clinical efficacy trials typically seen with PMA devices or certain novel technologies.
§ 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.