MedCommons Open Radiology™ Gateway (MedCommons Gateway™) is a software application for viewing medical images. Typical MedCommons Gateway™ users are healthcare professionals, such as, clinicians, radiologists, and technologists.

MedCommons Gateway™ receives, communicates, and displays digital images and data from various types of imaging and image processing system, such CT, MR, US, RF units, computed and direct radiographic devices, scanners, imaging gateways and image processing sources). MedCommons Gateway™ can be integrated with an institution's HIS or RIS, linking or transferring images and data into electronic patient records.

Device Description

MedCommons Open Radiology™ Gateway (MedCommons Gateway™) is a component of a Picture Archiving and Communications System (PACS). MedCommons Gateway™ is a software application that provides image viewing and manipulation in a diagnostic imaging setting. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM and/or other proprietary formats. MedCommons Gateway™ can also transfer DICOM 3.0 images over a medical imaging network, as well as export images to applications in JPEG and/or proprietary formats.

AI/ML Overview

The provided text is a 510(k) summary for the MedCommons Open Radiology™ Gateway. This document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (eFilm Workstation) based on device description, intended use, and similar features. It is a regulatory submission for market clearance, not a report of a performance study with specific acceptance criteria.

Therefore, I cannot provide the requested table and study details. The document explicitly states:

Substantial Equivalence: The MedCommons Open Radiology™ Gateway is substantially equivalent to the eFilm Workstation, which was cleared in 510(k)'s K020995 and K012211.
Comparison to the predicate device: The MedCommons Open Radiology™ Gateway and the eFilm Workstation are both software applications intended for viewing medical images stored in PACS systems. They have similar features and are substantially equivalent in safety and effectiveness.

This indicates that the clearance was based on similarity to an already approved device, rather than a new clinical performance study with defined acceptance criteria and subsequent testing against them for this specific device.

Summary

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JUL 27 2004

510(k) Summary for the MedCommons Open Radiology™ Gateway

This 510(k) summary of safety and effectiveness information complies with 21 CFR 807.92.

Submittal information:

Manufacturer: MedCommons, Inc. 52 Marshall Street Watertown, MA 02472

Contact person: Adrian Gropper, M.D. Chief Medical Officer MedCommons, Inc. 52 Marshall Street Watertown, MA 02472

(617) 571-3857

Device name and classification

Proprietary Name:	MedCommons Open Radiology™ Gateway
Classification Name:	Picture Archiving and Communications System
Classification Panel:	Radiology
CFR Section:	21 CFR 892.2050
Class:	II
Product Code:	LLZ

Substantial Equivalence

The MedCommons Open Radiology™ Gateway is substantially equivalent to the eFilm Workstation, which was cleared in 510(k)'s K020995 and K012211.

Device Description

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Intended Use

MedCommons Open Radiology™ Gateway (MedCommons Gateway™ is a software application for viewing medical images. Typical MedCommons Gateway™ users are healthcare professionals, such as, clinicians, radiologists, and technologists.

Comparison to the predicate device

The MedCommons Open Radiology™ Gateway and the eFilm Workstation are both software applications intended for viewing medical images stored in PACS systems. They have similar features and are substantially equivalent in safety and effectiveness.

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Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with its wings spread and head turned to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 27 2004

MedCommons, Inc. % Mr. Chas Burr Consultant SoftwareCPR, Inc. 11 Mystic Avenue WINCHESTER MA 01890-2920 Re: K041326 Trade/Device Name: MedCommons Open Radiology™ Gateway Regulatory Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: May 17, 2004

Received: May 18, 2004

Dear Mr. Burr:

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 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.

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 (QS) 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. Brydon

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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K041326

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _ MedCommons Open Radiology™ Gateway ____________________________________________________________________________________________________________________________

Indications for Use:

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Croydon

(Division Sign-Division of Reproductiv and Radiological Devices 510(k) Number

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).