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K Number
K213081
Device Name
CLISIS SYSTEMS, Discovery RF180
Manufacturer
General Medical Merate S.P.A
Date Cleared
2021-10-26

(33 days)

Product Code
IZF,IZI,JAA,KXJ,MQB
Regulation Number
892.1740
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CLISIS SYSTEMS, Discovery RF180 is indicated for performing general radiography, fluoroscopy and angiography procedures.

Applications and techniques:

  • Gastroenterology
  • Skeleton
  • Thorax and lungs
  • Paediatrics
  • Urology and gynecology
  • Emergency/traumatology
  • Digital angiography
  • Linear tomography
  • Auto Image Paste (Stitching)
  • Tomosynthesis
Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the CLISIS SYSTEMS, Discovery RF180, a tomographic x-ray system. It states the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.

However, the provided text DOES NOT contain any information regarding acceptance criteria or the study that proves the device meets those criteria. It is a regulatory clearance document, not a detailed technical report or clinical study summary.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance
  2. Sample size used for the test set and the data provenance
  3. Number of experts used to establish the ground truth
  4. Adjudication method
  5. MRMC comparative effectiveness study details
  6. Standalone performance
  7. Type of ground truth used
  8. Training set sample size
  9. How ground truth for the training set was established

The document focuses on the regulatory approval process and the intended uses of the device, not the technical details of its performance or the studies conducted to validate that performance. To obtain that information, one would typically need to refer to separate study reports, a detailed 510(k) summary (if available publicly with more technical details), or an Instructions for Use (IFU) document if it contains performance specifications.

§ 892.1740 Tomographic x-ray system.

(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.