(83 days)
Not Found
No
The document describes a standard PACS workstation with image viewing, manipulation, and networking capabilities, with no mention of AI or ML features.
No
The device is described as a PACS workstation software used for reviewing, interpreting, manipulating, and visualizing medical images to aid in diagnosis, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section states: "When interpreted by a trained physician, reviewed images can be used as an element for diagnosis." This directly indicates its role in the diagnostic process.
Yes
The device description explicitly states that it "may be marketed as software only". While it can also be packaged with hardware, the software-only option is presented as a valid configuration.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- UniPACS Workstation function: The UniPACS Workstation software is designed to review, interpret, manipulate, and visualize medical image data (like X-rays, CT scans, MRIs). It works with images, not biological samples.
- Intended Use: The intended use clearly states it's for reviewing and interpreting medical image data for diagnosis, not for performing tests on biological samples.
Therefore, the UniPACS Workstation falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
UniPACS Workstation software is intended to be used as a fully-functional, PCbased PACS software application, to review, interpret, manipulate, network, print and visualize medical multi-modality image data in DICOM format. When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.
Product codes
LLZ
Device Description
The UniPACS Workstation is a Windows-based software application acting as stand alone Picture Archiving and Communications System (PACS). It may be marketed as software only, as well as packaged with standard "off-the-shelf" PC hardware.
The comprehensive set of tools provided in this software allows the physician to review, interpret, manipulate, print and visualize medical image data stored in DICOM format. The networking component of the product allows the physician to exchange image data with any other DICOM-compatible or FTP-compatible server over a standard TCP/IP network. The web component of the product displays workstation images in the web-browser interface, for remote review and reporting.
The device does not contain the patient, nor does it control any life sustaining devices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical multi-modality image data in DICOM format
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including but not limited to physicians, nurses and technicians.
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)
eFilm Workstation (K012211, see also K020995)
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
Ko2 3476
JAN 0 7 2003
B. Administrative Information
1. 510(k) Summary of Safety and Effectiveness
Date Prepared
October 8, 2002
Submitter's Information
Universal PACS, Inc. 127 Albert Hart Drive Baton Rouge, LA 70803 Phone: (225) 766-9381
Contact Person
John M. Tyler, CEO, Universal PACS, Inc. Phone: (225) 766-9381 (225) 578-2198 Email: tyler@bit.csc.lsu.edu
Device
Trade Name: UniPACS Workstation Picture Archiving and Communications System Common Name: PACS (per 21 CFR 892.2050), LLZ, Class II Classification Name:
Substantially Equivalent To
eFilm Workstation (K012211, see also K020995)) eFilm Medical Inc. 500 University Ave, Suite 300 Toronto, Ontario Canada M5G 1V7 www.efilm.ca
1
Device Description
The UniPACS Workstation is a Windows-based software application acting as stand alone Picture Archiving and Communications System (PACS). It may be marketed as software only, as well as packaged with standard "off-the-shelf" PC hardware.
The comprehensive set of tools provided in this software allows the physician to review, interpret, manipulate, print and visualize medical image data stored in DICOM format. The networking component of the product allows the physician to exchange image data with any other DICOM-compatible or FTP-compatible server over a standard TCP/IP network. The web component of the product displays workstation images in the web-browser interface, for remote review and reporting.
The device does not contain the patient, nor does it control any life sustaining devices.
Indications for Use
UniPACS Workstation software is intended to be used as a fully-functional, PCbased PACS, to review, interpret, manipulate, network, print and visualize medical multi-modality image data in DICOM format. When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.
Typical users of this system are trained professionals, including but not limited to physicians, nurses and technicians.
Technological Comparison to Predicate Device
The proposed (UniPACS) and predicate (eFilm) devices are both software programs that can be used for manipulation of DICOM-compliant images on PC hardware. The proposed and predicate software can be operated from a personal computer, and provide a standard set of features with respect to image processing, storage and networking. The detailed feature comparison between the UniPACS Workstation and the eFilm Workstation demonstrates that, except a few minor, unimportant differences, the UniPACS Workstation provides the users with functionality, equivalent to that of the eFilm Workstation predicate device. This is a strong proof that the UniPACS and eFilm PACS Workstations are substantially equivalent.
Conclusion
Universal PACS Inc. considers the UniPACS Workstation to be substantially equivalent to the eFilm Workstation (K012211) device. The 510(k) Premarket Notification for the UniPACS Workstation contains adequate information and data to enable FDA-CDRH to determine substantial equivalence to the predicate device.
The UniPACS Workstation PACS software will be manufactured in accordance with the voluntary standards and development techniques listed in the submission. The software does not result in any new potential safety risks and performs as stated in its intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 7 2003
Mr. John M. Tyler CEO Universal PACS, Inc. 127 Albert Hart Drive BATON ROUGE LA 70803 Re: K023476
Trade/Device Name: UniPACS Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II
Product Code: 90 LLZ Dated: October 8, 2002 Received: October 16, 2002
Dear Mr. Tyler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- FDA Statement of Indications for Use
Kaz 3476 510(k) Number (if known)
Device Name: UniPACS Workstation
Indications for Use:
UniPACS Workstation software is intended to be used as a fully-functional, PCbased PACS software application, to review, interpret, manipulate, network, print and visualize medical multi-modality image data in DICOM format. When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.
Typical users of this system are trained professionals, including but not limited to physicians, nurses and technicians.
(PLEASE DO NO WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
-OR-
Prescription Use . (Per 21 CFR 801.109) Over-The-Counter Use
Daniel A. Searson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K023476