(15 days)
Not Found
No
The document describes image registration algorithms but does not mention AI, ML, or deep learning. The performance studies focus on compliance with standards and verification/validation testing, not AI/ML specific metrics or training/test data.
No.
The device's intended use is to help physicians in diagnostic radiology or therapy planning by providing 3D image registration for comparison of images from various modalities, but it does not directly apply therapy. It is described as a tool for planning, not delivering, therapeutic interventions.
No
The device is described as a tool for comparing and registering medical images from various modalities (CT, MRI, PET, SPECT, XA) to assist physicians in diagnostic radiology or therapy planning. Its core function is image processing and comparison, not the act of making a diagnosis itself. It supports diagnosis or therapy planning but does not perform diagnostic functions independently.
No
The device is described as an "extension to the Volume Viewer application" which runs on "Advantage Workstation 4.5 or higher versions." This implies the software is part of a larger hardware system (the Advantage Workstation), and not a standalone software-only device.
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.
- Device Function: The INTEGRATED REGISTRATION device processes and compares medical images (CT, MRI, PET, SPECT, XA) acquired from the human body. It does not perform tests on biological samples.
- Intended Use: The intended use is for image comparison to help physicians in diagnostic radiology or therapy planning. This is a function related to medical imaging analysis, not in vitro testing.
- Device Description: The description clearly states it's a tool for registering and comparing volumetric datasets from imaging modalities.
- Lack of Biological Sample Handling: There is no mention of handling or analyzing biological samples in the provided text.
Therefore, the INTEGRATED REGISTRATION device falls under the category of medical imaging software or image processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
INTEGRATED REGISTRATION permits comparison of three-dimensional (3D) images from Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Emission Tomography (PET or SPECT) and X-Ray Angiography (XA) to help physicians in diagnostic radiology or therapy planning.
INTEGRATED REGISTRATION provides easy means for comparison of three-dimensional (3D) images from Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Emission Tomography (PET or SPECT) and X-Ray Angiography (XA). To help physicians in diagnostic radiology or therapy planning, INTEGRATED REGISTRATION allows 3D registration between volumetric acquisitions that may come from the same acquisition modality or from different acquisition modalities.
Product codes (comma separated list FDA assigned to the subject device)
90LLZ
Device Description
The INTEGRATED REGISTRATION tool runs on Advantage Workstation 4.5 or higher versions. This product is an extension to the Volume Viewer application, dedicated to the registration of multi-modality images, and comparison of volumetric datasets from Computed Tomography (CT), Magnetic Resonance (MR), Positron Emission Tomography (PET) or Single Photon Emission Computed Tomography (SPECT), and 3D X-Ray Angiography (XA). Note that the INTEGRATED REGISTRATION licenses control which algorithms are available and which modalities can be saved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Emission Tomography (PET or SPECT), X-Ray Angiography (XA)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians in diagnostic radiology or therapy planning
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, INTEGRATED REGISTRATION, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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).
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093234
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
OC1 3 0 2009
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | October 8th, 2009 |
|---|---|
| Submitter: | GE Healthcare, (GE Medical Systems SCS) |
| 283, rue de la Minière | |
| 78530 Buc - FRANCE | |
| Primary Contact Person: | Sophie Le Loarer |
| Regulatory Affairs Specialist | |
| GE Healthcare, (GE Medical Systems SCS) | |
| TEL: (33) 1 30 70 43 31 - FRANCE | |
| FAX: (33) 1 30 70 41 00 - FRANCE | |
| Secondary Contact Person: | Stephen G. Slavens, RAC |
| Global Regulatory Affairs Director | |
| GE Healthcare, (GE Medical Systems LLC) | |
| TEL: (262) 548-4992 | |
| FAX: (262) 548-3884 | |
| Device: Trade Name: | INTEGRATED REGISTRATION |
| Common/Usual Name: | INTEGRATED REGISTRATION |
| Classification Name: | 21CFR 892.2050 Picture archiving and communications system |
| Product Code: | 90LLZ |
| Predicate Devices: | K010336: Advantage Windows CT/PET Fusion |
| K983256: Advantage Windows (CT/MR) Fusion | |
| K022310: Advantage Windows X-Ray/MR Fusion | |
| Device Description: | The INTEGRATED REGISTRATION tool runs on Advantage |
| Workstation 4.5 or higher versions. This product is an extension | |
| to the Volume Viewer application, dedicated to the registration of | |
| multi-modality images, and comparison of volumetric datasets | |
| from Computed Tomography (CT), Magnetic Resonance (MR), | |
| Positron Emission Tomography (PET) or Single Photon Emission | |
| Computed Tomography (SPECT), and 3D X-Ray Angiography | |
| (XA). Note that the INTEGRATED REGISTRATION licenses | |
| control which algorithms are available and which modalities can | |
| be saved. | |
| Intended Use: | INTEGRATED REGISTRATION permits comparison of three- |
| dimensional (3D) images from Computed Tomography (CT), | |
| Magnetic Resonance Imaging (MRI), Emission Tomography | |
| (PET or SPECT) and X-Ray Angiography (XA) to help | |
| physicians in diagnostic radiology or therapy planning. | |
| Technology: | INTEGRATED REGISTRATION consists of optimized |
| registration algorithms for pairs of modality images, | |
| configuration options as licensed by the end user, and protocols | |
| for use within each configuration option. | |
| INTEGRATED REGISTRATION is an optimized combination | |
| of its predicate devices and employs the same fundamental | |
| scientific technology as these predicate devices. |
Major improvements to the device include:
2D, 3D and hybrid 2D/3D Fusion capabilities The ability to load multiple (more than two) series and
multiple modalities (CT, MR, PET, SPECT, XA) in the same
registration session Registration results propagation to all the supported
modalities Optimized algorithms for modality pairs and anatomies Default registration at load Optimized tools for manual and regional registration, Reset, center and undo/redo tools to improve the usability, Protocols and layouts dedicated to typical clinical use cases, Saving ability for the new DICOM Registration Object Easier access to GE Radiotherapy simulation software:
Advantage Sim MD |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests:
INTEGRATED REGISTRATION complies with DICOM
Standard NEMA PS 3.1 - 3.18(2008). The following quality
assurance measures were applied to the development of the
system:
Risk Analysis Requirements Reviews Design Reviews Performance testing (Verification) Safety testing (Verification) Final acceptance testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, INTEGRATED
REGISTRATION, did not require clinical studies to support
substantial equivalence. |
| Conclusion: | GE Healthcare considers the INTEGRATED REGISTRATION
Software application to be as safe, as effective, and performance
is substantially equivalent to the predicate devices. |
Image /page/0/Picture/6 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are in black, while the background is white. The logo has a vintage or classic appearance.
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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. There are three teardrop-shaped elements positioned around the circle, one at the top and two at the bottom, adding a distinctive touch to the design.
510(k) Premarket Notification Submission
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・
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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines.
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
General Electric Medical Systems SCS % Mr. Daniel W. Lehtonen Senior Staff Engineer-Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 TWINSBURG OH 44087
Re: K093234
OCT 3 0 2009
Trade/Device Name: Integrated Registration Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 14, 2009 Received: October 15, 2009
Dear Mr. Lehtonen:
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); medical device reporting (reporting of medical
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Page 2 -
Enclosure
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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GE Healthcare 510(k) Premarket Notification Submission
510(k) Number (if known): K093234
Device Name: INTEGRATED REGISTRATION
Indications for Use:
INTEGRATED REGISTRATION provides easy means for comparison of three-dimensional (3D) images from Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Emission Tomography (PET or SPECT) and X-Ray Angiography (XA). To help physicians in diagnostic radiology or therapy planning, INTEGRATED REGISTRATION allows 3D registration between volumetric acquisitions that may come from the same acquisition modality or from different acquisition modalities.
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 Device Evaluation (ODE)
Torya M. Whiz
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K093234