RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE

K982862 · Applicare Medical Imaging, B.V. · LLZ · Oct 21, 1998 · Radiology

Device Facts

• Record ID: K982862
• Device Name: RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE
• Applicant: Applicare Medical Imaging, B.V.
• Product Code: LLZ · Radiology
• Decision Date: Oct 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The RadWorks Medical Imaging Software, from Applicare Medical Imaging, B.V., when installed on an appropriate hardware platform, is intended to provide capability for the acceptance, display, storage, and digital processing of medical images. Options allow for additional capability, including transmission of images over local area networks or public communications channels, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review and revision of studies.

Device Story

RadWorks Medical Imaging Software with Quality Control Module; software-based system for medical image management. Inputs: digital images from medical modalities; film images via digitization. Operations: acceptance, display, storage, digital processing, and quality control review. QC functions: confirm/edit patient characteristics, review study history, add/remove images, combine studies, renumber images, edit orientation, set routing. Used by authorized staff in clinical environments. Output: processed/managed imaging studies for network distribution. Benefits: ensures data integrity and study organization before clinical availability.

Clinical Evidence

Bench testing only. Software testing followed internal procedures, including development of a test plan, documentation of test procedures, expected results, and recording of results.

Technological Characteristics

Software-based digital image communications system. Operates on appropriate hardware platforms. Functions include image acceptance, display, storage, processing, and network transmission. No specific hardware materials or energy sources defined beyond standard computing equipment.

Indications for Use

Indicated for use by authorized staff to perform quality control operations on medical imaging studies, including patient data verification, image management, and routing, prior to network distribution.

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

• RadWorks Medical Imaging Software (K962699)

Submission Summary (Full Text)

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K982862

# 510(k) Summarv

# RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE

Common/Classification Name: Digital Image Communications System

Applicare Medical Imaging, B.V. P. O. Box 936 3700AX Zeist The Netherlands [phone] FAX [phone]

> Contact: Bernie van Welt Prepared: July 6, 1998

# LEGALLY MARKETED PREDICATE DEVICES A.

The RadWorks Medical Imaging Software with Quality Control Module is substantially equivalent to the original version of the RadWorks Medical Imaging Software (K962699).

#### DEVICE DESCRIPTION B.

The RadWorks Quality Control Module is intended to be used by authorized staff to perform various quality control operations on RadWorks imaging studies before they are made available to other locations on the network. These operations include confirming or editing patient characteristics, reviewing the status history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.

#### C. INTENDED USE

The RadWorks Quality Control Module is intended to be used by authorized staff to perform various quality control operations on RadWorks imaging studies before they are made available to other locations on the network. These operations include confirming or editing patient characteristics, reviewing the status history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.

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# D. TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the modified device are identical to those of the original device.

## E. TESTING

Software testing of the new module followed Applicare's normal procedures. During the design phase, a software test plan is developed, containing a detailed description of relevant test procedures. Each test procedure is documented and contains a description of what to test, what the expected results are, when to test, by whom the tests will be performed, which resources (such as automated test tools) will be used and how the test results are recorded.

### F. CONCLUSIONS

In summary, Applicare has demonstrated that the intended use for RadWorks Medical Imaging Software with Quality Control Module is the same as that of the original (predicate) device, and the technological characteristics have been described in sufficient detail to demonstrate that they are the same as those of the predicate device. Therefore, this premarket notification has demonstrated Substantial Equivalence as defined and understood in the Food, Drug, & Cosmetic Act and its amendments.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Applicare Medical Imaging, B.V. c/o T. Whit Athey, Ph.D. C.L. McIntosh & Associates 12300 Twinbrook Parkway, Suite 625 Rockville, MD 20852

K982862

Re:

RadWorks Medical Imaging Software with Quality Control Module Dated: August 13, 1998 Received: August 13, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Dr. Athey:

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 exclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice Jabeling; and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or 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 requirements, as set forth in the Quality System Regulation (QS) for Modisol 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(1) 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 80V-and additionally 809.10 for in ritin 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/odrf/dsma/dsmamain.html".

Sincerely yours,

William Yip, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K (332862

Device Name: RadWorks Medical Imaging Software with Quality Control Module

Indications For Use:

The RadWorks Medical Imaging Software, from Applicare Medical Imaging, B.V., when installed on an appropriate hardware platform, is intended to provide capability for the acceptance, display, storage, and digital processing of medical images. Options allow for additional capability, including transmission of images over local area networks or public communications channels, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review and revision of studies.

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510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel C. Bergman

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use