(13 days)
CT-C3000 System is intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.
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This document is a 510(k) summary for the Neusoft CT-C3000 Spiral CT Scanner System. As such, it describes the device and its intended use but does not contain information about acceptance criteria or specific studies proving the device meets those criteria, nor details about ground truth, sample sizes, or expert adjudication for performance evaluation.
The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to present novel clinical performance data meeting specific acceptance criteria.
The information provided only includes:
General Information about the Device:
- Trade Name: CT-C3000 Spiral CT Scanner System
- Common Name: CT Scanner
- Classification Name: Computed Tomography X-ray System (21 CFR Part 892.1750)
- Classification: Class II
- Performance Standard: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard; UL 187, Standard for safety, X-ray Equipment; IEC60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety.
- Manufacturer/Distributor: Neusoft Digital Medical System Co., Ltd.
- Indications for Use: CT-C3000 System is intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.
§ 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.