iQ-System PACS is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.

Device Description

iQ-System PACS is a software device for network or web-based medical image viewing and manipulation, running on Windows 2000/XP. It is adapted for, storing, processing routing and report generating. iQ-System PACS fully supports the DICOM standard and has functionality for advanced DICOM viewing, Hanging Protocol, and 3D image processing (Orthogonal and Oblique Multiplanar Reconstructions (MPR), Maximum Intensity Projections (MIP), Surface Shaded Display (SSD), and Volume Rendering (VRT)). The main iQ-SYSTEM PACS modules are iQ-LITE, iQ-Print, iQ-View (including iQ-3D), and iQ-Web.

AI/ML Overview

The provided text is a 510(k) summary for the iQ-System PACS. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about specific acceptance criteria or a study proving the device meets them in the way typically expected for performance-based AI/device evaluations.

This 510(k) is for a Picture Archiving Communications System (PACS) from 2006, which primarily deals with image viewing, manipulation, storage, and communication. At that time, the regulatory landscape and testing methodologies for PACS systems focused more on DICOM compliance, software functionality, and safety aspects rather than quantitative, statistically significant performance metrics like accuracy, sensitivity, or specificity for diagnostic tasks.

Therefore, many of the requested sections (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable or detailed in this type of submission.

Here's a breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria or performance metrics (like accuracy, sensitivity, specificity) for diagnostic tasks. The primary "acceptance criteria" for a PACS system like this, as implied by the 510(k) process, are:

Acceptance Criteria (Implied from 510(k) focus)	Reported Device Performance (from summary)
Substantial Equivalence to Predicate Device	Determined to be substantially equivalent to predicate device (K052358) by FDA.
DICOM Standard Support	iQ-System PACS fully supports the DICOM standard.
Image Viewing & Manipulation Functionality	Functionality for advanced DICOM viewing, Hanging Protocol, Orthogonal and Oblique Multiplanar Reconstructions (MPR), Maximum Intensity Projections (MIP), Surface Shaded Display (SSD), and Volume Rendering (VRT).
Image Capture, Storage, Communication, Processing	Images and data can be captured, stored, communicated, processed, and displayed.
Safety - Hazard Analysis	Submission contains results of a hazard analysis; "Level of Concern" classified as "Minor".
No Primary Diagnostic Use for Lossy Mammograms	Lossy compressed mammographic images... must not be reviewed for primary diagnosis or image interpretation. (This is a limitation, not a performance claim, but implies an "acceptance criterion" of safe use).
Monitor/Light Conditions Responsibility	User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application. (Another limitation/user responsibility.)

2. Sample size used for the test set and the data provenance

Not Applicable / Not Provided. This document does not describe a clinical validation study involving a test set of medical images evaluated for diagnostic accuracy. The testing would have focused on software functionality, DICOM compliance, and safety.
The document implies general medical imaging data (CT, MR, CR, DR, US) but does not specify a provenance for a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided. As no specific diagnostic performance test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method for the test set

Not Applicable / Not Provided. No test set or ground truth adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a PACS viewer, not an AI-assisted diagnostic tool. An MRMC study comparing human readers with and without AI assistance is not described and would not typically be performed for this type of general PACS system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. The iQ-System PACS is a tool for human interpretation and management of images, not a standalone diagnostic algorithm. No standalone performance study is described.

7. The type of ground truth used

Not Applicable / Not Provided. For a PACS system, ground truth in the diagnostic sense is not its direct function. Its "ground truth" relates to its ability to accurately display the source DICOM data. Compliance with DICOM standards and verification of image integrity are implicitly tested, but not framed as "ground truth" for diagnostic outcomes.

8. The sample size for the training set

Not Applicable / Not Provided. This device is a software system for image management and viewing, not a machine learning or AI algorithm that requires a "training set" in the context of data-driven learning. Its development would involve software engineering and testing, not statistical training on medical images.

9. How the ground truth for the training set was established

Not Applicable / Not Provided. As it's not an AI/ML device, there's no concept of a training set or its associated ground truth.

Summary

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SEP 1 9 2006

K062488

Page 1 of 2

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

August 17, 2006

Submitter's Information: 21 CFR 807.92(a)(1)

Mr. Arpad Bischof MD IMAGE Information Systems Ltd. 15 Perham Road London, W14 9SR United Kingdom Phone: +44 207 904 18 51 Fax: +44 207 904 18 52

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name:	iQ-System PACS
Common Name:	Picture Archiving Communications System
Classification Name:	system, image processing, radiological
Product code:	LLZ

Predicate Device: 21 CFR 807, 92(a)(3)

FDA has classified the predicate device (K052358) as Class II, CFR 892.2050, LLZ. It is our understanding that iQ-System PACS device falls under the same classification as the predicate device. Predicate device details are as follows:

Device Classification Name system, image processing, radiological

510(k) Number	K052358
Regulation Number	892.2050
Device Name	ETIAM STAR PACS COMPONENTS
Applicant	ETIAM, S.A.
Classification Product Code	LLZ
Decision Date	10/05/2005

Device Description: 21 CFR 807 92(a)(4)

iQ-System PACS is a software device for network or web-based medical image viewing and manipulation, running on Windows 2000/XP. It is adapted for, storing, processing routing and report generating.

iQ-System PACS fully supports the DICOM standard and has functionality for advanced DICOM viewing, Hanging Protocol, and 3D image processing (Orthogonal and Oblique Multiplanar Reconstructions (MPR), Maximum Intensity Projections (MIP), Surface Shaded Display (SSD), and Volume Rendering (VRT)). The main iQ-SYSTEM PACS modules are iQ-LITE, iQ-Print, iQ-View (including iQ-3D), and iQ-Web.

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Indications for Use: 21 CFR 807 92(a)(5)

Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.

Technological Characteristics: 21 CFR 807 92(a)(6)

iQ-System PACS is a software device that handles and manipulates digital medical images.

The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification iQ-System PACS contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The submission contains the results of a hazard analysis and the "Level of Concern" for potential hazards has been classified as "Minor".

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP 1 9 2006

IMAGE Information Systems Ltd. % MR. Carl Alletto Consultant OTech. Inc. 1600 Manchester Way CORINTH TX 76201

Re: K062488

Trade/Device Name: iQ-System PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 10, 2006 Received: August 29, 2006

Dear Mr. Alletto:

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 (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center, with the word "Centennial" underneath. The bottom of the logo contains additional text, and there are three stars in between the word Centennial and the text at the bottom. The logo appears to be a commemorative emblem for the FDA's centennial anniversary.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any 1 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 CI It Fat 6017, laboring (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you've begal finding of substantial equivalence of your device to a legally premaince holicated 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 11 you teen office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 (2 CF F F at the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.ltml.

Sincerely yours,

Nancy C. Hogdon

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

Enclosure

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(Indications for Use Form)

510(k) Number: K062488

Device Name: iQ-System PACS

Indications for Use:

iQ-System PACS is a software device intended for viewing of images acquired from CT, IQ-System I ACS is a software do Hoo moliant medical imaging systems when installed on suitable commercial standard hardware.

Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be Dossy colliprosod manimograpins image interpretation. It is the User's responsibility to reviewed for primal y diagnolis of this. and image compression ratios are consistent with clinical application.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓ (Part 21 CFR 801 Subpart D)
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AND/OR

Over-The-Counter Use	(21 CFR 807 Subpart C)
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Carolyn Y Newbold for NCBiogden

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number	2062488
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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).