(49 days)
Not Found
No
The document describes image post-processing software with standard analysis tools and does not mention AI, ML, or related concepts.
No
The device is a post-processing software application for analyzing MRA images to assist clinicians in evaluating vascular anatomy and disease, rather than directly treating or mitigating a condition.
Yes
The device is intended to facilitate "vascular anatomy and pathology analysis" and can be used for "vascular disease assessment," assisting clinicians in the "evaluation and assessment of vascular anatomy and disease," which are all diagnostic functions.
Yes
The device is described as a "software application" and a "software package" that runs on existing hardware platforms (Advantage Workstation and AW Server). It processes DICOM images and provides analysis tools, without mentioning any proprietary hardware components included with the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- MR VessellQ Xpress Function: The description clearly states that MR VessellQ Xpress is a post-processing software application that analyzes Magnetic Resonance Angiographic (MRA) images. MRA images are generated from a medical imaging procedure performed on the patient's body, not from a sample taken from the body.
- Intended Use: The intended use is to facilitate the analysis of vascular anatomy and pathology from MRA images, assisting clinicians in evaluating vascular disease. This is an image analysis tool, not a diagnostic test performed on a biological sample.
Therefore, MR VessellQ Xpress falls under the category of medical image analysis software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
MR VessellQ Xpress is intended to provide an optimized non-invasive application to facilitate vascular anatomy and pathology analysis from a set of DICOM 3.0 compliant 3D contrastenhanced Magnetic Resonance Angiographic (MRA) images.
MR VessellQ Xpress is a post processing application which can be used in the analysis of MRA data for the purpose of vascular disease assessment. ·
This software is designed to assist radiologists and other clinicians in the evaluation and assessment of vascular anatomy and disease with the capability to provide a set of tools for visualizing directional vessel tortuosity, for sizing the vessel and for measuring areas of abnormalities within a vessel.
Product codes
LLZ, LNH
Device Description
MR VessellQ Xpress is a post processing analysis software application designed to assist Radiologists, Cardiologists, and other clinicians in the evaluation and assessment of vascular anatomy.
MR VessellQ Xpress is a software package for the Advantage Workstation (AW) platform and AW Server platform. The MR VessellQ Xpress is an additional tool for the 2D and 3D analysis of DICOM compliant MR angiographic images/data , providing a number of display, measurements and batch filming/archive features to study user-selected vessels which include but are not limited to stenosis analysis and directional vessel tortuosity visualization.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Angiographic (MRA) images
Anatomical Site
Vascular anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists, Cardiologists, and other clinicians
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 subject of this premarket submission, MR VessellQ Xpress did not require clinical studies to support substantial equivalence.
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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K122164
p. 1 of 3
SEP 7 2012
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
July 19th, 2012 Date:
Submitter: GE Medical Systems SCS 283, Rue de la Minière 78530 Buc. France Helen Peng, RAC Primary Contact Person: Regulatory Affairs Leader GE Healthcare 3000 North Grandview Blvd. W1140 Waukesha, WI 53188, USA Tel: 262-548-5091 Fax: 262-364-2506 Email: hong.peng@ge.com
Secondary Contact Person:
Stephen Slavens , RAC Regulatory Affairs Director GE Healthcare 3000 North Grandview Blvd, W1140 Waukesha, WI 53188, USA Tel: 262-548-4992
Fax: 262-364-2506
MR VessellQ Xpress
Email: Stephen.slavens@ge.com
Class II per 21 CFR 892.2050
Ali
Advanced Vessel Analysis MR (AVA MR)
Picture, Archiving and Communication System
Device: Trade Name: Common/Usual Name: Classification Names:
Product Code:
LLZ
Predicate Device(s):
K041521 Volume Viewer Plus by GE Medical Systems
K040746 MRA-CMS by Medis Medical Imaging Systems
Device Description:
MR VessellQ Xpress is a post processing analysis software application designed to assist Radiologists, Cardiologists, and other clinicians in the evaluation and assessment of vascular anatomy.
MR VessellQ Xpress is a software package for the Advantage Workstation (AW) platform and AW Server platform. The MR VessellQ Xpress is an additional tool for the 2D and 3D analysis
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K122164
p. 2 of 3
GE Healthcare 510(k) Premarket Notification Submission
of DICOM compliant MR angiographic images/data , providing a number of display, measurements and batch filming/archive features to study user-selected vessels which include but are not limited to stenosis analysis and directional vessel tortuosity visualization.
MR VessellQ Xpress is intended to provide an optimized non-Intended Use: invasive application to facilitate vascular anatomy and pathology analysis and vascular disease assessment from a set of DICOM 3.0 compliant Magnetic Resonance Angiographic (MRA) images.
MR VessellQ Xpress is intended to provide an optimized non-Indication for Use invasive application to facilitate vascular anatomy and pathology analysis from a set of DICOM 3.0 compliant 3D contrast-enhanced Magnetic Resonance Angiographic (MRA) images.
MR VessellQ Xpress is a post processing application which can be used in the analysis of MRA data for the purpose of vascular disease assessment.
This software is designed to assist radiologists and other clinicians in the evaluation and assessment of vascular anatomy and disease with the capability to provide a set of tools for visualizing directional vessel tortuosity, for sizing the vessel and for measuring areas of abnormalities within a vessel.
The MR VesselIQ Xpress employs the same fundamental Technology: scientific technology as its predicate devices.
Image /page/1/Picture/9 description: The image shows a blurry, black and white drawing. It is difficult to discern the exact subject of the drawing due to the low resolution and lack of detail. The image appears to be a rough sketch or a low-quality reproduction of a more detailed image.
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K122164
p. 3 of 3
GE Healthcare
510(k) Premarket Notification Submission
Determination of Substantial Equivalence:
The MR VessellQ Xpress and its components comply with the following voluntary standards :
NEMA PS 3.1 - 3.18(2008) Digital Imaging and Communications in Medicine (DICOM) Set.
MR VessellQ Xpress was designed in compliance with the following Process Standards:
- ISO 13485 Quality Systems-Model for Quality . assurance in design, development, production, installation and servicing of medical device
- ISO 14971 Medical devices-Application of Risk . management to medical devices
- IEC 62304 Medical device software Software life . cycle processes
- IEC 62366. -Medical devices Application of usability . engineering to medical devices
- .
The following quality assurance measures were applied to the development of the device:
-
. Risk Analysis
Summary of Non-Clinical Tests: -
Requirements Reviews .
-
Design Reviews .
-
. Unit level testing (Module Verification)
-
Integration testing (System verification) �
-
Final acceptance testing (Validation)
-
Performance testing (Verification)
-
Safety testing (Verification)
Summary of Clinical Tests:
The subject of this premarket submission, MR VessellQ Xpress did not require clinical studies to support substantial equivalence.
MR Vessell() Xpress does not result in any new potential safety Conclusion: risks and performs as well as the predicate devices currently on the market. GE Medical Systems SCS considers the MR VessellQ Xpress to be as safe, as effective as, and is substantially equivalent to the predicate devices.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.
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
GE Medical Systems SCS % Ms. Helen Peng Regulatory Affairs Leader GE Medical Systems, LLC dba GE Healthcare 3000 N. Grandview, W1140 WAUKESHA WI 53188
SEP 7 2012
Re: K122164
Trade/Device Name: MR VesselIQ Xpress Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ and LNH Dated: July 19, 2012 Received: July 20, 2012
Dear Ms. Peng:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your becamined the device is substantially equivalent (for the indications and for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars annual date of the Medical Device American Continuents, or to commerce provision in May 20, 1976, the encordance with the provisions of the Federal Food. Drug, uevices that have been recuire approval of a premarket approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket You may, therefore, market the device, subject to the general controls provisions of the Act. The Act. The Y ou may, therefore, market the devices, ediferents for annual registration, listing of general controls provisions of the rice, 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 II your device is Classified (see above) into enas ffecting your device can be found in Title 21, additional controls. Existing mayor regards a 895. In addition, FDA may publish further Ode of Pederal concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuation with the router with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA lias made a determination and regulations administered by other Federal station and light or ally Federal statutes and regulations and limited to: registration and listing (21 Compy with all the Act 3 requirements, arrants 801 and 809); medical device reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-lefated adverse events) (21 CFR Pat 3-60 ), and 820). This letter requirents as set form in the quality Systems (QS) reged in your Section 510(k) prematket will allow you to ocgin marketing your actively walence of your device to a legally marketed notification. The I DFI imaing of successification 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 II you desire specific advice for your device of the career Evaluation and Safety at (301) 796-607), please contact 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 under the MDK regulation (27 ℃FR Part 005), producem/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 Tou may other other general meeting 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
Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circle. There are small swirls or flourishes around the letters and the outer edge of the circle, giving it a classic and recognizable design.
GE Healthcare 510(k) Premarket Notification Submission
K122164 510(k) Number :
MR VessellQ Xpress Device Name:
Indications for Use:
MR VessellQ Xpress is intended to provide an optimized non-invasive application to facilitate vascular anatomy and pathology analysis from a set of DICOM 3.0 compliant 3D contrastenhanced Magnetic Resonance Angiographic (MRA) images.
MR VessellQ Xpress is a post processing application which can be used in the analysis of MRA data for the purpose of vascular disease assessment. ·
This software is designed to assist radiologists and other clinicians in the evaluation and assessment of vascular anatomy and disease with the capability to provide a set of tools for visualizing directional vessel tortuosity, for sizing the vessel and for measuring areas of abnormalities within a vessel.
Prescription Use_X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K122164