RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3

• K Number: K032924
• Device Name: RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
• Manufacturer: VOLUME INTERACTIONS PTE LTD
• Date Cleared: 2003-10-10 ( 18 days)
• Product Code: LLZ
• Regulation Number: 892.2050
• Type: Special
• Panel: RA
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Volume Interactions Pte Ltd's Image Processing System is a medical device for the display and visualization of 3D medical image data derived from CT and MRI scans. It is intended to be used by qualified and trained medial professionals, after proper installation.

Volume Interactions Pte Ltd's Image Processing System is not intended to be used in direct contact with the patient nor is it intended to be connected to equipment that is used in direct contact with the patient.

Device Description

Image Processing System (RadioDexter™ 1.0, Dextroscope™ MK10, and Dextrobeam™ MK3)

AI/ML Overview

This FDA 510(k) clearance letter for the "Image Processing System (RadioDexter™ 1.0, Dextroscope™ MK10, and Dextrobeam™ MK3)" does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria.

The letter primarily:

• Confirms the device's substantial equivalence to a legally marketed predicate device.
• States the device's classification (Class II, Product Code 90 LLZ).
• Outlines general regulatory requirements for marketing the device.
• Includes an "Indications for Use Statement" that describes the device's purpose: "a medical device for the display and visualization of 3D medical image data derived from CT and MRI scans" and that it's "intended to be used by qualified and trained medical professionals, after proper installation."

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Details on experts or ground truth for a test set.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. How training set ground truth was established.

This document is a regulatory clearance and does not typically include the detailed technical study information you are asking for. That information would usually be found within the 510(k) submission itself, which is not provided in these pages.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).