ImageLink™ is an integrated medical imaging solution that allows for the storage, manipulation, and annotation of high resolution digital radiological images from multiple source modalities. It enhances the efficiency of diagnostic decision making and includes a feature-rich viewer with customizable worklists and hanging protocols that can be organized to meet the unique requirements and style of the individual radiologist.

Device Description

ImageLink is designed to fit seamlessly into the hospital's existing IT infrastructure, integrating with the CPSI HIS/RIS systems. Patient and order information is shared with CPSI clinical applications providing real-time update of the PACS worklist and DICOM Modality Worklist files, notification of completed orders and signed transcriptions, and quick access to the study throughout the enterprise.

This product conforms to recognized industry standards such as DICOM, JPEG, ACR, and others as applicable.

Support for the following modalities will be provided:

· CR
· CT
· MR
· NM
RF
US
DX
PT
XA
· OT
· MG

The CPSI ImageLink application software includes the following major components: ImageLink Server, ImageLink Viewer, and ImageLink/ChartLink Interface for web viewing. These software applications, combined with the hardware platform and networking infrastructure, make up the ImageLink System.

AI/ML Overview

The provided documentation does not contain any information about acceptance criteria or a study proving the device meets them. The 510(k) summary for ImageLink (K112096) primarily focuses on:

Device Description and Intended Use: Explaining what the device is and what it's for.
Predicate Device Comparison: Establishing substantial equivalence to a previously cleared PACS system (GE Medical Systems, Information Technologies Centricity PACS System K043415).
Compliance with Standards: Mentioning adherence to standards like DICOM, JPEG, ACR, 21 CFR 820.30, and ISO 14971 for design, development, and risk analysis.

The section titled "F.10 Test Summary" states that "The design and development process of ImageLink™ complies with standards listed in section I of this submission," and mentions adherence to "change control principles based upon 21 CFR 820.30" and "Risk Analysis in ISO 14971." However, these statements refer to process compliance rather than specific performance metrics or a clinical/bench study demonstrating functional equivalence or meeting predefined acceptance criteria for diagnostic performance.

Therefore, I cannot provide the requested information, as it is not present in the given text.

Specifically, the following information is NOT available in the provided text:

A table of acceptance criteria and the reported device performance: No such table or performance data is presented.
Sample size used for the test set and the data provenance: No test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
Adjudication method: Not applicable as no test set or ground truth is described.
Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The device is a PACS system, not an AI-assisted diagnostic tool in the sense that would typically require MRMC studies for improved reader performance.
Standalone performance (algorithm only without human-in-the-loop performance): This is not applicable as the device is a PACS system designed for human interaction and use. No standalone algorithm performance is discussed.
Type of ground truth used: No ground truth is described.
Sample size for the training set: No training set is described.
How the ground truth for the training set was established: No training set or ground truth establishment is described.

The submission focuses on establishing substantial equivalence based on intended use, device description, materials, target population, and environment, along with compliance with relevant medical device regulatory and quality standards for its development. It does not detail specific performance studies or acceptance criteria comparisons that might be expected for an AI-enabled diagnostic device.

Summary

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K112096
p. 1 of 3

510(k) Summary

Section F	510(k) Summary
F.1	Submission Date
07/19/2011
F.2	Submitter/Owner
	Computer Programs and Systems, Incorporated (CPSI)
F.2.A	Owner / Operator Number
	905588
F.2.B	Establishment Registration Number
	3004120479
F.2.C	Contact Person
	Michael Hunt, Software Services, CPSI
F.2.D	Address
	6600 Wall StreetMobile, AL 36695
F.2.E	Phone
	1.800.711.2774
F.2.F	Fax
	251.639.8214
F.3	Device Trade Name
	ImageLink
F.4	Common Name
	Picture Archiving Communications System (PACS)
F.5	Classification Names
	Product Code:	LLZ
	Device:	System, Image Processing Radiological
	Regulation:	21 CFR 892.2050

F.6 Predicate Device

The legally marketed device to which CPSI claims equivalence is found in 510(k) number K043415 and is called Centricity PACS System, manufactured by GE Medical Systems, Information Technologies.

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K112096
P. 2 of 3
510(k) Summary

F.7 Device Description

This product conforms to recognized industry standards such as DICOM, JPEG, ACR, and others as applicable.

Support for the following modalities will be provided:

· CR
· CT
· MR
· NM
RF
US
DX
PT
XA
· OT
· MG

F.8 Intended Use

F.9 Technology

The ImageLink Server provides a scalable, storage solution for medical images. Utilizing standard DICOM communications protocols, the server accepts images stored to it from authorized modalities, and also provides these modalities with worklists. The server also provides medical image studies to the ImageLink viewer when requested.

All archived image data is preserved in the format in which is it received by the ImageLink Server. The ImageLink server employs presentation states to store any changes such as annotations, editing, or image manipulations performed on the images. All manipulations and annotations can be reversed in the system to provide the user with the original images unchanged.

The ImageLink Viewer is used to view, analyze, edit, compare, annotate, store, and

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K112096
P. 3 of 3

510(k) Summary

distribute images and data stored in the ImageLink server.

The ImageLink/ChartLink web interface allows the viewing of medical images from the archive, over secure web connections through the CPSI ChartLink application. The application can be accessed internally by hospital uses or with authentications. externally over the World Wide Web. The web interface is not intended for primary diagnosis.

Diagnostic workstations running the viewer must meet minimum requirements for safety, performance and effectiveness including display capabilities of no less than 3 mega pixels.

F.10 Test Summary

The design and development process of ImageLink™ complies with standards listed in section I of this submission. Further ImageLink was developed and modified with change control principles based upon 21 CFR 820.30 as specified in section Q.1. Overall Quality Assurance activities of ImageLink is furthered by adherence to the principles of Risk Analysis in ISO 14971.

F.11 Summary of Characteristics to that of the Predicate

CPSI ImageLinkTM is substantially equivalent to its predicate device, GE Medical Systems, Information Technologies Centricity PACS System (K043415). Both devices are similar in intended use, device description, materials used, the target population and intended environment for use. Both devices consist of a hardware platform, server application software, image viewing software, and web tools. There are minor differences in terms of technology employed as well as minor functional differences with configurable hotkeys, integration with historical reports and voice clip. These differences do not detract from the equivalence claim.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Michael Hunt Software Analysits, Software Services Computer Programs and Systems, Inc. (CPSI) 6600 Wall Street MOBILE AL 36695

SEP 3 0 2011

Re: K112096 Trade/Device Name: ImageLink™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 19. 2011 Received: July 22, 2011

Dear Mr. Hunt:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 1 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Section E Indications for Use Statement

E.1 Statement

Indications for Use

510(k) Number (if known):

Device Name: ImageLinkTM

Indications For Use:

× _ AND/OR Over-The-Counter Use_ Prescription Use

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Patel
(Division Sign-Off)

Office of In Vitro Di

510K K112096

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).