(10 days)
This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration.
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy
The Multislice kit is an upgrade to previously cleared Aquilion CT Scanner, TSX-101A; [K982265]. This upgrade will allow for the collection of eight axial slices in one scan. This is accomplished by employing multiple solid state detectors. This methodology allows for the acquisition of high resolution slices while maintaining the speed required to reduce anatomical motion artifacts.
This 510(k) summary (K020385) describes an upgrade kit for a CT scanner and does not include a study with acceptance criteria or device performance data as typically found in clinical validation studies for AI/ML devices. Therefore, I cannot provide the requested information.
The document focuses on:
- Device Description: An upgrade to an existing CT scanner (Aquilion TSX-101A) to allow for the collection of eight axial slices in one scan using multiple solid-state detectors.
- Intended Use: Standard CT imaging for various body parts and conditions, similar to already cleared devices.
- Technological Characteristics: Employs the same core technology as the predicate device, with differences only in subassembly component composition.
- Safety and Effectiveness Concerns: Adherence to Quality System Regulations (21 CFR Part 820), Federal Diagnostic Equipment Standard (21 CFR § 1020.30 and 1020.33), and IEC-60601 Medical Device Safety standards.
- Substantial Equivalence: Claimed based on similarity to the CGS-22A upgrade kit, with the main difference being the number of slices collected per rotation.
No performance metrics, study designs, sample sizes, or ground truth methodologies are detailed within this document, as it is a summary for a hardware upgrade to an existing, already cleared device, not a new AI/ML algorithm requiring such rigorous clinical performance evaluation for market clearance in the context of AI.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.