RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3 by VOLUME INTERACTIONS PTE LTD

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:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for a test set.
Details on experts or ground truth for a test set.
Adjudication methods.
MRMC comparative effectiveness study results.
Standalone performance details.
Type of ground truth used.
Training set sample size.
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.

Summary

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Image /page/0/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird in flight, composed of three curved lines that suggest movement and wings. Encircling the bird is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES' in a circular arrangement. The logo is simple and iconic, likely representing a government agency related to health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2003

Mr. John Baby Regulatory Affairs Manager Volume Interactions PTE LTD 5 Shenton Way #37-04 UIC Building, 068808 SINGAPORE

Re: K032924

Trade/Device Name: Image Processing System (RadioDexter™ 1.0, Dextroscope™ MK10, and Dextrobeam™ MK3) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: September 15, 2003 Received: September 22, 2003

Dear Mr. Baby:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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Version 1.0

Attachment 2

Indications for Use Statement

510(K) Number

KO32924

Image Processing System Device Name

Indications for Use

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broadon

(Division Sign Division of Reproductive. and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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).