(70 days)
No
The document describes a standard PACS image viewing and manipulation software and does not mention AI, ML, or related concepts.
No
The device is a software application for viewing medical images, which is specifically stated to be a component of a Picture Archiving and Communications System (PACS). Its function is to facilitate the display and transfer of medical images and data, not to directly treat or diagnose a medical condition.
Yes
The device is described as providing "image viewing and manipulation in a diagnostic imaging setting," and its users are explicitly healthcare professionals such as "clinicians, radiologists, and technologists" who use it for viewing medical images. This indicates its role in the diagnostic process.
Yes
The device description explicitly states that MedCommons Gateway™ is a "software application" and a "component of a Picture Archiving and Communications System (PACS)". There is no mention of accompanying hardware being part of the device itself.
Based on the provided information, the MedCommons Open Radiology™ Gateway (MedCommons Gateway™) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body (in vitro).
- MedCommons Gateway™ Function: The description clearly states that MedCommons Gateway™ is a software application for viewing medical images. It receives, communicates, and displays digital images from imaging modalities like CT, MR, US, etc. These are images of the inside of the body, not specimens taken from the body.
- Intended Use: The intended use is for healthcare professionals to view and manipulate medical images for diagnostic imaging purposes. This is distinct from analyzing biological samples.
The device is a component of a PACS system, which is used for managing and viewing medical images. This aligns with the description of a medical imaging device, not an IVD.
N/A
Intended Use / Indications for 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.
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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, US, RF units, computed and direct radiographic devices, scanners, imaging gateways and image processing sources
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals, such as, clinicians, radiologists, and technologists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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.
1
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.
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.
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.
2
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.
3
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
4
K041326
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _ MedCommons Open Radiology™ Gateway ____________________________________________________________________________________________________________________________
Indications for 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.
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.
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