(63 days)
Not Found
No
The summary describes image analysis software with advanced processing techniques but does not mention AI, ML, or related concepts like neural networks or deep learning. The focus is on processing existing MR data sets using established methods like time series analysis, diffusion imaging, and spectroscopy.
No
The device is an image analysis software designed to aid in diagnosis by processing medical images, not to provide direct therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software "may provide clinically relevant information for diagnosis," and the "Mentions image processing" section notes that it "provides advanced techniques to aid in the diagnosis of neurological and oncological diseases."
Yes
The device is described as "image analysis software" and a "suite of applications" that processes data from MR generated data sets. While it runs on a workstation, the description focuses solely on the software's functionality and does not mention any hardware components being part of the device itself.
Based on the provided text, 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.
- Device function: READY View is an image analysis software that processes MR generated data sets. This data comes from medical imaging, not from samples taken from the body.
- Intended Use: The intended use describes processing and analyzing medical images to provide information for diagnosis. This is distinct from performing tests on biological samples.
Therefore, READY View falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
READY View is an image analysis software that allows the user to process dynamic or functional volumetric data and to generate maps that display changes in image intensity over time, echo time, b-value (Diffusion imaging) and frequency (Spectroscopy). The combination of acquired images, reconstructed images, calculated parametric images, tissue segmentation, annotations and measurement performed by the clinician allows multiparametric analysis and may provide clinically relevant information for diagnosis.
Product codes
LLZ
Device Description
READY View is a suite of applications developed to improve multiparametric exams by enabling the analysis of MR generated data sets containing multiple images for each scan location. The MR data sets may be any of the following:
- . A time series
- A diffusion weighted scan .
- A diffusion tensor scan .
- . A variable echo imaging
- A blood oxygen level dependent imaging .
- Spectroscopy (Single voxel and 2D or 3D CSI) ●
The READY View platform provides a combination of protocols, applications and tools that enables a fast, easy and quantified analysis of the multiple data sets.
Brain View is a post processing image analysis software package that provides advanced techniques to aid in the diganosis of neurological and oncological diseases. Brain View is an option with the READY View platform and offers two advanced protocols:
- . FiberTrak
- . Arterial Spin Labeling (ASL)
READY View along with Brain View option is available on the Advantage Workstation (AW) and Advantage Workstation Server Gen 2, for viewing and processing Magnetic Resonance images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR
Anatomical Site
Brain, Breast, Prostate, and Liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Summary of Non-Clinical Tests:
The following quality assurance measures were applied to the development of READY View:
- Risk Analysis .
- Requirements Reviews .
- Design Reviews .
- . Performance testing (Verification)
- . Safety testing (Verification)
- . Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, READY View, 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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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circular frame. The letters and the frame are solid black, creating a strong contrast against the white background.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
MAY - 3 2011
In accordance with 21 CFR 807.92 the following summary of information is provided: Date: February 25, 2011
- Submitter: GE Healthcare (GE Medical Systems SCS) Establishment Registration Number - 9611343 283, Rue de la Minière 78533 Buc, France
- Elizabeth Mathew Primary Contact Person: Regulatory Affairs Leader - MR GE Healthcare, (GE Medical Systems, LLC) Establishment Registration Number - 2183553 3200 N Grandview Blvd., Mail Stop: W-827 Waukesha, WI - 53188, USA Phone: (262) 521-6658 Fax: (262) 521-6439
- Secondary Contact Person: Glen Sabin Regulatory Affairs Director - MR GE Healthcare, (GE Medical Systems, LLC) Establishment Reaistration Number - 2183553 3200 N Grandview Blvd., Mail Stop: W-827 Waukesha, WI - 53188, USA Phone: (262) 521-6848 Fax: (262) 364-2785
- Device: Trade Name: READY View
- Common/Usual Name: READY View
Classification Names: 21 CFR 892.2050 Picture archiving and communication system
90 LLZ Product Code:
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The letters are connected and have a swirling design. The logo is black and white.
GE Healthcare . 510(k) Premarket Notification Submission
FuncTool Option for Advantage Windows (K960265) Predicate Device(s): Volume Viewer Plus (K041521)
Device Description:
READY View is a suite of applications developed to improve multiparametric exams by enabling the analysis of MR generated data sets containing multiple images for each scan location. The MR data sets may be any of the following:
- . A time series
- A diffusion weighted scan .
- A diffusion tensor scan .
- . A variable echo imaging
- A blood oxygen level dependent imaging .
- Spectroscopy (Single voxel and 2D or 3D CSI) ●
The READY View platform provides a combination of protocols, applications and tools that enables a fast, easy and quantified analysis of the multiple data sets.
Brain View is a post processing image analysis software package that provides advanced techniques to aid in the diganosis of neurological and oncological diseases. Brain View is an option with the READY View platform and offers two advanced protocols:
- . FiberTrak
- . Arterial Spin Labeling (ASL)
READY View along with Brain View option is available on the Advantage Workstation (AW) and Advantage Workstation Server Gen 2, for viewing and processing Magnetic Resonance images.
READY View is an image analysis software that allows the user to Intended Use: process dynamic or functional volumetric data and to generate maps that display changes in image intensity over time, echo time. b-value (Diffusion imaging) and frequency (Spectroscopy). The combination of acquired images, reconstructed images, calculated parametric images, tissue segmentation, annotations and measurement performed by the clinician allows multi-parametric analysis and may provide clinically relevant information for diagnosis.
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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are black, contrasting with the white background. The logo is a well-known symbol associated with the multinational conglomerate corporation.
GE Healthcare
510(k) Premarket Notification Submission
Technology:
READY View is a post-processing application processing MR functional data of the human body acquired from a MR Scanner. Taraeted anatomy includes but is not limited to Brain, Breast, Prostate, and Liver.
Functional data sets contain a series of sequentially ordered images for each scan location, where the interval between images can represent time, b-value, echo time, gradient orientation or ppm value (frequency) depending on the data set.
The pixel value in an area of interest at a given scan location may have a different value for each image. To analyze these changes in pixel values, READY View provides two tools:
- Graphs: the pixel values at a given pixel location are plotted . as a graph. The graphs can then be represented by the pixel value over the image number or the pixel value over time, bvalue, echo time, gradient orientation or ppm value.
- . Functional images: for each pixel location, the pixel values from the images are used to compute a characteristic parameter by means of a function. A functional map is then constructed by displaying the value of the parameter for each pixel location.
The READY View software employs the same algorithm technology as its predicate device FuncTool (K960265), Like FuncTool, READY View provides protocols that enable a fast, easy and quantified analysis of the multiple data sets.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The following quality assurance measures were applied to the development of READY View:
- Risk Analysis .
- Requirements Reviews .
- Design Reviews .
- . Performance testing (Verification)
- . Safety testing (Verification)
- . Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, READY View, did not require clinical studies to support substantial equivalence.
GE Healthcare considers READY View to be as safe, as effective, and Conclusion: performance 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 stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
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 Healthcare (GE Medical Systems SCS) % Ms. Elizabeth Mathew Regulatory Affairs Leader GE Healthcare (GE Medial Systems, LLC) 3200 N. Grandview Blvd., Mail Stop: W-827 WAUKESHA WI 53188
MAY - 3 2011
Re: K110573
Trade/Device Name: READY View Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 25, 2011 Received: March 1, 2011
Dear Ms. Mathew:
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 intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, 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, inte not 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
4
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 to a legally market 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 (30) 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/Reportals.go to
of Surveillance.and Riometrias/Safety/Reportalers/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 on Consumer Assistance at its toll the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary S Patel
Mary S. Pastel, Sc.D. 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/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined inside a circle. There are three decorative swirls around the circle, one at the top and two at the bottom.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Number (if known): [INSERT 510(k) NUMBER IF KNOWN] READY View Device Name:
Indications for Use
READY View is an image analysis software that allows the user to process dynamic or functional volumetric data and to generate maps that display changes in image intensity over time, echo time, b-value (Diffusion imaging) and frequency (Spectroscopy). The combination of acquired images, reconstructed images, calculated parametric images, tissue seqmentation, annotations and measurement performed by the clinician allows multiparametric analysis and may provide clinically relevant information for diagnosis.
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
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(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)
Page 1 of
Mary Spotte
(Division Sign-Off)
Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110573