(26 days)
K#982146
No
The document describes a standard PACS system for image management and viewing. There is no mention of AI, ML, or any features that would typically involve such technologies for image analysis, diagnosis, or workflow optimization beyond basic image compression.
No
The device is a Picture Archiving and Communication System (PACS) used by radiology professionals to manage medical images and information. It is not intended to treat or cure any medical condition.
No
The device is indicated for capturing, storing, distributing, and displaying radiological images. It does not perform any analysis or interpretation of the images to diagnose medical conditions, but rather acts as an information and image management system.
No
The device description explicitly mentions "Image capture is available from most imaging modalities using DICOM interfaces and selected non-DICOM interfaces," implying interaction with hardware modalities for image acquisition, which is not characteristic of a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for capturing, storing, distributing, and displaying radiological images and information. This is related to medical imaging, not the examination of specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description details a Picture Archiving and Communication System (PACS) that integrates images and information from various imaging modalities. This aligns with medical imaging workflows, not in vitro testing.
- No mention of biological specimens: There is no mention of the device interacting with or analyzing biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
Therefore, PACSPlus, version 2.0, falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Dynamic PACSPlus is a powerful image management tool designed for use by technologists. radiologists and other healthcare professionals. Dynamic PACSPlus is fully compatible with the RADPlus and Maxifile RIS as well as other Hospital and Radiology Information Systems. The product provides client/server-based multimedia results viewing and distribution.
Dynamic Healthcare Technologies' PACSPlus, version 2.0, is indicated for use by radiology professionals to capture, store, distribute and display radiological images and information over local and Wide Area Networks. The only editing of the images is via the wavelet lossy compression feature, using the Pegasus PICtools ™ Medical Compression toolkit, a 510(k)-cleared medical device product (K#982146).
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
"Dynamic PACSPlus Version 2.0 is an information-enabled PACS (Picture Archiving and Communication System) that integrates all information from the RIS with images from PACS. Image capture is available from most imaging modalities using DICOM interfaces and selected non-DICOM interfaces. PACSPlus InfoBroker Servers are used as gateways that capture the DICOM images, reconcile the DICOM information with order information from the RIS, and provide access to additional exam and patient information including results. The PACSPlus Image and Information Server stores, indexes, and distributes images and information. Images can be viewed through the web-based Dynamic WebSight viewer. Exams can be accessed by patient identifiers, location, or by physician. The entire imaging exam history is shown (film and digital) to allow the viewer to select any results or available digital images. "
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
most imaging modalities using DICOM interfaces and selected non-DICOM interfaces.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
technologists. radiologists and other healthcare 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K#982146
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEC 8 1998 SUMMARY OF SAFETY AND EFFECTIVENESS for SPECIAL 510(k) MODIFICATION SUBMISSION
DEVICE CLASSIFICATION NAME: PACS System (Picture Archiving and Communications System) 892.2050 REGULATION NUMBER: PACS System (Picture Archiving and Communications COMMON/USUAL NAME: System) PACSPlus, version 2.0 TRADE/PROPRIETARY NAME: PREVIOUS 510(k) DEVICE NAME: MaxiView Radiology Workstation PREVIOUS 510(k) DEVICE NUMBER: K930500 ESTABLISHMENT LICENSE NO .: 1933179
REASON FOR SPECIAL 510(k) SUBMISSION:
The predicate device has been modified to incorporate changes in technology. A comparison chart is included as a part of the Special 510(k) submission.
SYSTEM DESCRIPTION:
"Dynamic PACSPlus Version 2.0 is an information-enabled PACS (Picture Archiving and Communication System) that integrates all information from the RIS with images from PACS. Image capture is available from most imaging modalities using DICOM interfaces and selected non-DICOM interfaces. PACSPlus InfoBroker Servers are used as gateways that capture the DICOM images, reconcile the DICOM information with order information from the RIS, and provide access to additional exam and patient information including results. The PACSPlus Image and Information Server stores, indexes, and distributes images and information. Images can be viewed through the web-based Dynamic WebSight viewer. Exams can be accessed by patient identifiers, location, or by physician. The entire imaging exam history is shown (film and digital) to allow the viewer to select any results or available digital images. " (source: Product Fact Sheet, Dynamic Healthcare Technologies, Inc.)
INTENDED USE:
Dynamic PACSPlus is a powerful image management tool designed for use by technologists. radiologists and other healthcare professionals. Dynamic PACSPlus is fully compatible with the RADPlus and Maxifile RIS as well as other Hospital and Radiology Information Systems. The product provides client/server-based multimedia results viewing and distribution.
SAFETY STATEMENT:
Dynamic Healthcare Technologies, Inc.'s PACSPlus product, version 2.0, is a set of software applications and interfaces that do not directly come into contact with the patient. Further, as specified in our Users' Guide, this product is intended for use by trained professionals only, who utilize their education and experience to evaluate and review the data obtained and make a decision using that professional judgement. We believe this software product to be a safe and effective device to be on the market.
CONTACT INFORMATION:
Dynamic Healthcare Technologies, Inc. 615 Crescent Executive Center, Fifth Floor Lake Mary, FL 32746-2109
1
Image /page/1/Picture/0 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" around the perimeter. Inside the circle is an abstract image of what appears to be an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
10008 DEC ರ್ಧ
Karen White Senior Consultant, Regulatory Affairs Dynamic Healthcare Technologies, Inc. 615 Crescent Executive Court Fifth Floor Lake Mary, FL 32746
Re: K984023
Dynamic PACSPLUS™ Version 2.0 Dated: November 12, 1998 Received: November 12, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Ms. White:
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 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 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 (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 (OS) for Medical Devices: General regulation (2) 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(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 and additionally 809.10 for in vitro diggiostic 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/dsmaldsmamain.html".
Sincerely yours,
Kilian Yiu
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal. Ear. Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K984023
Dynamic PACSPlus, version 2.0 Device Name:
Indications for Use Statement
Dynamic Healthcare Technologies' PACSPlus, version 2.0, is indicated for use by radiology professionals to capture, store, distribute and display radiological images and information over local and Wide Area Networks. The only editing of the images is via the wavelet lossy compression feature, using the Pegasus PICtools ™ Medical Compression toolkit, a 510(k)-cleared medical device product (K#982146).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vivid C. Segmen
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K984023
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
- .
(Optional Format 1-2-96)