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K Number
K965004
Device Name
C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC.
Date Cleared
1997-03-11

(85 days)

Product Code
JAK
Regulation Number
892.1750
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
N/A
Predicate For
K983140
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The C.A.R.E. VISION is intended to be used for instant display of CT images during interventional procedures using CT scanners. Instant image reconstruction of 3-9 images per second allows the physician to watch the placement of an interventional instrument real time.

Device Description

The C.A.R.E. VISION option is a new scan mode added to the SOMATOM Plus 4 CT scanner. The option can be installed in the SOMATOM Plus 4 CT as an upgrade kit consisting of hardware, software and firmware. Under C.A.R.E. VISION, three to nine images are reconstructed and displayed per second, effectively simulating a real-time display presentation. More than one C.A.R.E. VISION scans can be set-up and performed one after the other. C.A.R.E. VISION can also be mixed with other scan modes. Switch to SEQUENCE scan mode can be initiated any time during C.A.R.E. VISION thus a particular phase of the operation can be displayed in enhanced image quality.

AI/ML Overview

This document does not contain the information required to answer the request regarding acceptance criteria and device performance. The provided text is a 510(k) summary for the C.A.R.E. VISION Option for SOMATOM Plus 4 CT System, primarily focusing on its description, intended use, and substantial equivalence to predicate devices. It does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about a test set, its sample size, or data provenance.
  • Information on experts or ground truth establishment for a test set.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance.
  • The type of ground truth used.
  • Training set sample size or ground truth establishment for a training set.

The document discusses the device's ability to reconstruct and display 3-9 images per second, effectively simulating real-time, and its use during interventional procedures to guide instrument placement. However, it does not provide quantitative performance metrics or studies to prove acceptance criteria.

§ 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.