MEDIMAGE

K972215 · Vepro - Computersysteme GmbH · LLZ · Nov 19, 1997 · Radiology

Device Facts

• Record ID: K972215
• Device Name: MEDIMAGE
• Applicant: Vepro - Computersysteme GmbH
• Product Code: LLZ · Radiology
• Decision Date: Nov 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

MEDImage is a software-based Picture Archiving and Communications System (PACS). It acquires analogue and digital images from various medical modalities; stores and archives images and patient data on hard disks or long-term optical media; and enables retrieval for re-consultation, processing, and transmission. Used in clinical environments by trained medical professionals, the system facilitates the management of diagnostic radiological images. Healthcare providers use the displayed output to assist in clinical decision-making and primary diagnosis. The system operates on industry-standard hardware.

Clinical Evidence

No clinical data provided. The submission relies on hazard analysis and adherence to voluntary standards.

Technological Characteristics

Software-based PACS utilizing industry-standard hardware. Functions include image acquisition, storage (hard disk/optical media), retrieval, processing, and transmission. Operates in single-user or network environments.

Indications for Use

Indicated for use by trained medical professionals to acquire, display, process, archive, retrieve, and transmit diagnostic medical images and associated information in single-user or network environments.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Siemens PACS/I-A (K880690)

Submission Summary (Full Text)

{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. [phone] fax.[phone]

contact person:

Ms. Cissis Cox VEPRO-Computersysteme GmbH An der Tuchbleiche 26 D - 64319 Pfungstadt Germany tel. [phone] fax.[phone]

| 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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