(69 days)
No
The document describes standard medical image processing and quality control functions without mentioning AI or ML.
No.
This device is a medical imaging software intended for the acceptance, display, storage, and digital processing of medical images, and quality control operations. It does not provide any therapeutic effect or intervention.
No
The device is described as medical imaging software for the acceptance, display, storage, and digital processing of medical images, and for quality control operations. It does not perform any analysis or interpretation of images to derive a diagnosis or aid in diagnosis.
Yes
The device is described as "RadWorks Medical Imaging Software" and its function is centered around the processing, display, and management of medical images. While it requires an "appropriate hardware platform," the description focuses solely on the software's capabilities and does not mention any specific hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is focused on the acceptance, display, storage, and digital processing of medical images. This is related to image management and manipulation, not the analysis of biological samples or the diagnosis of disease based on in vitro tests.
- Device Description: The description of the Quality Control Module further reinforces this, detailing functions related to managing and editing image studies, not performing diagnostic tests on patient samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
- Focus on Image Processing: While it mentions "digital processing of medical images," this is in the context of image manipulation and management, not diagnostic analysis of the image content itself for the purpose of diagnosing a disease or condition.
The device appears to be a medical image management and processing software system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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.
Product codes
90 LLZ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical images, film images, digital images directly from different medical image modalities
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
authorized staff
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).
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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 +31-30-6926000 FAX +31-30-6926010
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.
1
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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Image /page/2/Picture/0 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
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
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 (301) 594-4643. 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/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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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