(100 days)
Not Found
Not Found
No
The document describes standard image processing and analysis tools (reformatting, rendering, display, calcium scoring, coronary analysis, vessel analysis) without mentioning AI or ML algorithms. The analysis features are described as semi-automatic, implying user interaction rather than autonomous AI/ML processing.
No.
The device is described as a software-based PACS for diagnostic review and analysis, not for treating any condition or disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The ResolutionMD software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists and nurses." It also mentions that "When interpreted by a trained physician, reviewed images may be used as an element for diagnosis." Furthermore, several modules like "Calcium Scoring module," "Coronary Analysis module," and "Vessel Analysis module" are described as being used for identification, quantification, and analysis of anatomical features relevant to diagnosis.
Yes
The device description explicitly states "The ResolutionMD(TM) is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware". This indicates the device itself is the software, and it relies on general-purpose hardware for its function, not specialized medical device hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- ResolutionMD's function: ResolutionMD is a software-based PACS used for displaying, visualizing, and analyzing medical images (CT, MRI). It processes image data, not biological specimens.
The text clearly describes the device's purpose as handling and analyzing medical images for diagnostic review and analysis by trained professionals. This falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ResolutionMD(TM) 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, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
The ResolutionMD software 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. Calgary Scientific recommends that users of the ResolutionMD software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.
ResolutionMD Web 2.9 is not to be used for mammography.
Calcium Scoring module: The ResolutionMD device incorporates a Calcium Scoring module which is used to identify and quantify calcified plaque within the coronary arteries. This protocol is performed on non-contrast enhanced cardiac CT data sets.
Coronary Analysis module: The ResolutionMD device incorporates a Coronary Analysis protocol which is used to visually identify and measure stenoses in the coronary arteries. This protocol is performed on contrast-enhanced cardiac CTA data sets.
Vessel Analysis module: ResolutionMD™ Web 2.9 incorporates a Vessel Analysis module which is used as a postprocessing diagnostic review and analysis application for images viewed from ResolutionMD™, a PACS workstation or DICOM image viewer. It is a tool for use by trained professionals such as physicians, technologists and surgeons to review, edit, analyze and report findings of vascular anatomy. Clinicians can semi-automatically determine contrasted lumen boundaries and stenosis measurements, and evaluate maximum and minimum lumen diameters and length measurements.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The ResolutionMD(TM) 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, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI
Anatomical Site
Coronary arteries (for Calcium Scoring and Coronary Analysis modules), vascular anatomy (for Vessel Analysis module)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals such as physicians, technologists, nurses, and surgeons.
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.
Not Found
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three overlapping, curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Kyle Peterson Director, Regulatory & Corporate Affairs Calgary Scientific Inc. 1210 20th Avenue SE, Suite 208 CALGARY ALBERTA T2G 1M8 CANADA
Re: K120076
Trade/Device Name: ResolutionMD™M Web 2.9 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 19, 2012 Received: March 21, 2012
Dear Mr. Peterson:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
APR 1 9 2012
1
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
510(k) Number: K120076
Device Name: ResolutionMD" Web 2.9
Indications for Use:
The ResolutionMD(TM) 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, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
The ResolutionMD software 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. Calgary Scientific recommends that users of the ResolutionMD software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.
ResolutionMD Web 2.9 is not to be used for mammography.
Prescription Use (Part 21CFR 801 Subpart D)
. AND/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 In Vitro Diagnostic Devices (OIVD)
Concurrence of CDRH)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K1200276 510(k)
3
510(k) Number: K120076
Device Name: ResolutionMD" Web 2.9
Indications for Use: Calcium Scoring module
The ResolutionMD(TM) 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, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
The ResolutionMD device incorporates a Calcium Scoring module which is used to identify and quantify calcified plaque within the coronary arteries. This protocol is performed on non-contrast enhanced cardiac CT data sets.
The ResolutionMD software 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. Calgary Scientific recommends that users of the ResolutionMD software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.
ResolutionMD Web 2.9 is not to be used for mammography.
Prescription Use _ (Part 21CFR 801 Subpart D)
AND/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 In Vitro Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K1200276
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | CONTRACTORS |
4
510(k) Number: K120076
Device Name: ResolutionMD" Web 2.9
Indications for Use: Coronary Analysis module
The ResolutionMD(TM) 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, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
The ResolutionMD device incorporates a Coronary Analysis protocol which is used to visually identify and measure stenoses in the coronary arteries. This protocol is performed on contrast-enhanced cardiac CTA data sets.
The ResolutionMD software 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. Calgary Scientific recommends that users of the ResolutionMD software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.
ResolutionMD Web 2.9 is not to be used for mammography.
Prescription Use (Part 21CFR 801 Subpart D)
AND/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 In Vitro Diagnostic Devices (OIVD)
Sommy Pearce
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K1200276 510(k)
5
510(k) Number: K120076
Device Name: ResolutionMD" Web 2.9
Indications for Use: Vessel Analysis module
ResolutionMD™ Web 2.9 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, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
ResolutionMD Web 2.9 incorporates a Vessel Analysis module which is used as a postprocessing diagnostic review and analysis application for images viewed from ResolutionMD™, a PACS workstation or DICOM image viewer. It is a tool for use by trained professionals such as physicians, technologists and surgeons to review, edit, analyze and report findings of vascular anatomy. Clinicians can semi-automatically determine contrasted lumen boundaries and stenosis measurements, and evaluate maximum and minimum lumen diameters and length measurements.
ResolutionMD Web 2.9 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. Calgary Scientific recommends that users of the ResolutionMD Web 2.9 consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.
ResolutionMD Web 2.9 is not to be used for mammography.
Prescription Use _ x (Part 21CFR 801 Subpart D)
AND/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 In Vitro Diagnostic Devices (OIVD)
Concurrence of CDRH, Office
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K1200276 510(k)