(159 days)
Not Found
No
The summary describes standard PACS functionality (image acquisition, display, processing, archiving, retrieval, transmission) and does not mention any AI/ML specific terms or capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is described as an image management system (PACS) for diagnostic radiological images, which typically falls under diagnostic imaging rather than therapeutic use.
Yes
The device is described as being used to "acquire, display, process, archive, retrieve, and transmit diagnostic radiological images and information about these images." The term "diagnostic radiological images" directly ties the device to the diagnostic process by handling the images from diagnostic procedures.
Yes
The device description explicitly states "MEDImage is a software package" and describes its functions as software-based operations (acquire, store, search, retrieve, process, transmit). While it interacts with hardware (hard disk, optical disks, industry standard equipment), the device itself is presented as a software entity.
Based on the provided information, MEDImage is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description of MEDImage clearly state that it is used to acquire, display, process, archive, retrieve, and transmit diagnostic radiological images. These are images of the human body itself, not specimens taken from it (like blood, urine, tissue samples, etc.).
- The focus is on imaging modalities. The input is described as "analogue and digital images from any modality," which refers to imaging equipment like X-ray, CT, MRI, etc.
- The intended use is for diagnostic radiological images. This directly relates to medical imaging, not laboratory testing of specimens.
Therefore, MEDImage falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MEDImage will be used to acquire, display, process, archive, retrieve, and transmit diagnostic radiological images and information about these images in a single user or network environment. Typical users of MEDImage are trained medical professionals.
Product codes
90 LLZ
Device Description
MEDImage is a software package designed to acquire analogue and digital images from any modality, store and archive these images together with patient information on hard disk and/or on long-term media such as standard optical disks; search for and retrieve these images for re-consultation, processing and/or transmission. MEDImage utilizes industry standard equipment.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Analogue and digital images from any modality
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
single user or network environment. Typical users of MEDImage are trained medical professionals.
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
Not Found
Key Metrics
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
Image /page/0/Picture/0 description: The image shows the company name and address of VEPRO GmbH. The address is An der Tuchbleiche 26, 64319 Pfungstadt. The text is black and the background is white.
Document Mail Center (HFZ - 401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Boulevard
Image /page/0/Picture/2 description: The image shows a logo with a check mark and the word "VEPRO" in bold letters. Below the logo, the word "Computersysteme" is written in a smaller font. The text "K972215" is handwritten below "Computersysteme". The date "NOV 1 9 1997" is printed at the bottom of the image.
Rockville, Maryland 20850 USA
510(K) SUMMARY
This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with requirements of SMDA 1990.
The undersigned certifies that the 510(k) Pre-Market Notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence to Siemens PACS/1-A (K880690). This data is summarized as follows:
- MEDimage has been and will be manufactured in accordance with the voluntary 1. standards listed in the enclosed voluntary standard survey.
- The MEDimage User's Guide contains comprehensive and extensive information on 2. how to operate the system.
- This submission contains the results of a hazard analysis. 3.
Submitter:
Harald G. Roth VEPRO-Computersysteme GmbH An der Tuchbleiche 26 D -64319 Pfungstadt Germany tel. (06157) 800 600 fax.(06157) 800 666
contact person:
Ms. Cissis Cox VEPRO-Computersysteme GmbH An der Tuchbleiche 26 D - 64319 Pfungstadt Germany tel. (06157) 800 600 fax.(06157) 800 666
| Summary Prepared on: | 06. June 1997 |
|---|---|
| ---------------------- | --------------- |
Trade name:
MEDImage
Common name:
Picture Archiving and Communications System (PACS)
1
Image /page/1/Picture/0 description: The image shows the logo for VEPRO Computersysteme. The logo features a large checkmark to the left of the word "VEPRO" in bold, sans-serif font. Below the word "VEPRO" is the word "Computersysteme" in a smaller, less bold font.
Classification name:
No formal classifications have been issued for Picture Archiving, and Communications Systems (PACS) or components, under Section 513 of the Food, Drug, and Cosmetic Act. Images from the VEPRO MEDImage system may be used for primary diagnosis as do other PACS Systems; however, these systems are not represented to be used in supporting or sustaining human life, nor do they present a potential for unreasonable risk of illness or injury. Evaluation of the output is performed by health care professionals and provides adequate opportunity for competent human intervention. Therefore, we believe that all digital archives meet the requirements of a Class I Device.
VEPRO claims Substantial Equivalence to: Siemens PACS/I-A (K880690)
Device Description:
MEDImage is a software package designed to acquire analogue and digital images from any modality, store and archive these images together with patient information on hard disk and/or on long-term media such as standard optical disks; search for and retrieve these images for re-consultation, processing and/or transmission. MEDImage utilizes industry standard equipment.
Intended Use:
MEDImage will be used to acquire, display, process, archive, retrieve, and transmit diagnostic radiological images and information about these images in a single user or network environment. Typical users of MEDImage are trained medical professionals.
2
Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 1997
Cissie Cox . Sales Support Vepro Computersysteme GMBH An der Tuchbleiche 26 D-64319 Pfungstadt, Germany
K972215 Medimage Dated: September 26, 1997 Received: October 2, 1997 Regulatory class: Unclassified Procode: 90 LLZ
Dear Ms. Cox:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrf/dsmamain.html".
Sincerely yours,
W. Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT 3
510(k) Number:_
Device Name: MEDImage
Indications For Use:
MEDImage will be used to acquire, display, process, archive, retrieve, and transmit diagnostic medical images and information about these images in a single user or network environment. The typical users are trained medical professionals.
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
V