(56 days)
Not Found
No
The summary describes standard PACS functionality for image display, processing, and 3D visualization, without mentioning any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is a PACS software for displaying and visualizing medical images to assist in diagnosis, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "ResolutionMD™ is intended for use as a diagnostic, review, and analysis tool... When interpreted by a trained physician, reviewed images may be used as an element for diagnosis."
Yes
The device description explicitly states "ResolutionMD™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware". It also mentions being available in Windows and Macintosh OS versions, further indicating it is a software product designed to run on existing hardware.
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 examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- ResolutionMD™ Functionality: ResolutionMD™ is a software-based PACS system that processes and displays medical images (CT and MRI) acquired from within the body. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for the display and visualization of medical image data for diagnostic, review, and analysis purposes by trained professionals. This aligns with the use of medical imaging devices, not IVDs.
Therefore, ResolutionMD™ falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ResolutionMD™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
ResolutionMD™ is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Product codes
LLZ
Device Description
ResolutionMD™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. The ResolutionMD™ software takes advantage of dedicated graphics hardware to speed the creation 3D rendered images.
ResolutionMDTM is available in a Microsoft Windows version and in a Macintosh OS version. Both versions offer similar functionality. Available functions include DICOM communication, display of 2D images in original planes, computation and display of rendered 3D images and maximal intensity projection (MIP) images, and 2D and 3D image measurements. The user controls these functions with a system of interactive menus and tools.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained Professionals such as physicians, technologists, and nurses.
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)
The ResolutionMD™ software has been extensively tested on a variety of platforms by both members of the development and quality control team and by potential customers serving as beta testers. A hazard analysis has been conducted and the level of concern has been classified as minor. The release version of the software passed all tests considered critical in terms of patient safety and demonstrated an overall acceptable performance for release as determined by the predefined release criteria.
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).
0
Kol 2164
5 510(k) Summary
| Date Prepared: | July 21, 2006 |
|---|---|
| Submitter's Name: | Calgary Scientific, Inc. |
| Submitter's Address: | 1210 20th Ave. SE, Calgary, Alberta, Canada T2G 1M8 |
| Submitter's Phone: | 403.270.7159 |
| Submitter's Fax: | 403.668.1689 |
| Contact: | Pierre Lemire, Chief Technology Officer |
| Proprietary Name: | ResolutionMD™ |
| Common Name: | Software PACS |
| Classification: | 892.2050 Picture archiving and communications system, |
| Product Code LLZ, (Class II) | |
| Substantially | |
| Equivalent to: | Tradename: Lucion |
| Manufacturer: Mevisys | |
| 510(k) Number: K050033 | |
| Tradename: Plug 'n View 3D | |
| Manufacturer: Voxar Limited | |
| 510(k) Number: K992654 | |
| Tradename: Vitrea 2 | |
| Manufacturer: Vital Images, Inc. | |
| 510(k) Number: K032748 |
Device Description:
ResolutionMD™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. The ResolutionMD™ software takes advantage of dedicated graphics hardware to speed the creation 3D rendered images.
ResolutionMDTM is available in a Microsoft Windows version and in a Macintosh OS version. Both versions offer similar functionality. Available functions include DICOM communication, display of 2D images in original planes, computation and display of rendered 3D images and maximal intensity projection (MIP) images, and 2D and 3D image measurements. The user controls these functions with a system of interactive menus and tools.
1
The ResolutionMD™ software has been extensively tested on a variety of platforms by both members of the development and quality control team and by potential customers serving as beta testers. A hazard analysis has been conducted and the level of concern has been classified as minor. The release version of the software passed all tests considered critical in terms of patient safety and demonstrated an overall acceptable performance for release as determined by the predefined release criteria.
| Feature | ResolutionMD™ | Mevisys
Lucion™ | Voxar Plug
'n View 3D™ | Vital
Vitrea 2™ |
|------------------------------------------|---------------------------------------------------------|--------------------|---------------------------|--------------------|
| Computer
Platform | Windows OS or
Mac OS | Windows OS | Windows OS | Windows OS |
| DICOM
compliance | DICOM 3.10 | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| 2D Imaging | 2D image viewer
with interactive
user controls | same | same | same |
| 3D Imaging | 3D volume
rendering with
interactive controls | same | same | same |
| Measurement | 2D measurement
tools | same | same | same |
| Maximum
Intensity
Projection (MIP) | MIP with
interactive controls
and clipping planes | same | same | same |
| Prescription Use | Yes | same | same | same |
| Intended Users | Trained
Professionals | same | same | same |
Substantial Equivalence Comparisons to Predicate Devices:
Intended Use:
ResolutionMD™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
ResolutionMD™ is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application.
2
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
3
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 2 2 2006
Mr. Pierre Lemire Chief Technology Officer Calgary Scientific, Inc. Suite 208-1210 20th Avenue SE Calgary, Alberta, T2G 1M8 CANADA
Re: K062164
Trade/Device Name: ResolutionMDTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 25, 2006 Received: July 28, 2006
Dear Mr. Lemire:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/10 description: The image is a circular logo with the letters "FDA" in the center. Above the letters, the numbers "1876-1976" are displayed, and below the letters, the word "Centennial" is written. Three stars are located at the bottom of the circle. The logo appears to be a commemorative emblem for the centennial of the FDA.
Protecting and Promoting Public Health
4
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.
This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
Applicant: Calgary Scientific, Inc., Suite 208 - 1210 20th Ave. SE, Calgary, Alberta, CANADA T2G 1M8
510(k) Number (if known):
ResolutionMD™M Device Name:
Indications for Use:
ResolutionMD™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
ResolutionMD™ is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)
ADD/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Lyymm
Division of Reproductive, Abdon and Radiological Devices 510(k) Number _
Confidential