LogoFDA 510(k) Search
K Number
K063189
Device Name
TSX-301A, AQUILION ONE CT SYSTEM
Manufacturer
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
Date Cleared
2006-11-03

(14 days)

Product Code
JAK
Regulation Number
892.1750
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Acquisition and display of axial x-ray images of the whole body to include the head.

Device Description

The TSX-301A/1 is a whole body CT scanner. This device produces axial images that may be reconstructed into 3-D volumes. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.

AI/ML Overview

This 510(k) premarket notification for the TSX-301A, Aquilion ONE CT System from Toshiba America Medical Systems, Inc. does not contain information regarding
acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document focuses on:

  • Device description: A whole-body CT scanner that produces axial images reconstructable into 3D volumes.
  • Intended Uses: To produce cross-sectional data sets of the anatomy.
  • Technological Characteristics: Similar materials and processes to its predicate device, the Toshiba TSX-101A/H Aquilion 64 SP CT scanner.
  • Safety and Effectiveness Concerns: Designed and manufactured under Quality System Regulations (21 CFR § 820.30) and Federal Diagnostic Equipment standards (21 CFR § 1020.30 and 1020.33). Conforms to applicable parts of IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-44.
  • Substantial Equivalence: Claimed to be substantially equivalent to the Toshiba TSX-101A/H Aquilion 64 SP CT scanner.
  • FDA Clearance: The FDA found the device substantially equivalent to a legally marketed predicate device on November 3, 2006.
  • Indications for Use: Acquisition and display of axial x-ray images of the whole body, including the head.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text.

§ 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.