SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL

• K Number: K982583
• Device Name: SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL
• Manufacturer: SHIMADZU CORP.
• Date Cleared: 1998-10-05 ( 73 days)
• Product Code: JAK
• Regulation Number: 892.1750
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K955255
• Predicate For: N/A

Intended Use

· This device is intended to be used in X-ray CT scanning on whole body.
· This device is operated and used by Physicians and X-ray technologist.
· The object of this device is total patient population.
As mentioned at " Intended Use " in this clearance letter, the intended use of the SCT-6800TXL is as same as that of predicate device SCT- 7000TX ( K955255) and there is no additional indication.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification letter from the FDA regarding an X-ray CT scanner. This document does not describe acceptance criteria or a study proving that a device meets acceptance criteria. It is a regulatory approval document confirming substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information from the provided text.

Regulation Number and Section

§ 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.