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K Number
K980837
Device Name
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS
Manufacturer
SHIMADZU MEDICAL SYSTEMS
Date Cleared
1998-05-20

(77 days)

Product Code
JAK
Regulation Number
892.1750
Type
Traditional
Panel
RA
Reference & Predicate Devices
K955255
Predicate For
K991553
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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.

Device Description

SCT-7000TS

AI/ML Overview

This is a 510(k) clearance letter for the Shimadzu Whole Body x-ray Computed Tomography Scanner SCT-7000TS, dated May 2, 1998. The letter states that the device is substantially equivalent to a predicate device marketed prior to May 28, 1976. This document does not provide details of acceptance criteria or a study proving the device meets acceptance criteria as would be found in a modern AI/ML device submission.

Here's why the requested information cannot be extracted from this document:

  • Date: This document is from 1998. The FDA's regulatory framework and submission requirements for medical devices, particularly concerning performance studies and validation for software-driven or AI/ML components, were significantly different and less detailed than they are today.
  • Device Type: The device is a "Whole Body x-ray Computed Tomography Scanner." While it is an imaging device, the focus of 510(k) submissions for such devices in 1998 was on demonstrating substantial equivalence to a predicate device, primarily in terms of safety and effectiveness related to its physical parameters, image quality, and intended use, rather than complex algorithm performance.
  • Content of 510(k) Letter: This is the clearance letter from the FDA, not the original 510(k) submission itself. It primarily states the FDA's decision and the regulatory class. The actual submission, if available, might contain some performance data, but it is highly unlikely to include the specific types of studies (MRMC, standalone AI performance data) and detailed ground truth methodologies that are common in modern AI/ML device submissions.

Therefore, I cannot provide the requested information. The document pertains to a traditional CT scanner from 1998 and does not describe acceptance criteria or a study in the context of AI/ML performance.

§ 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.