(13 days)
Not Found
No
The document describes image processing and analysis tools but does not mention AI, ML, or related terms. The performance studies focus on software validation and comparison to predicate devices, not on AI/ML model performance metrics.
No.
This device is a software package designed for image processing, analysis, and communication of medical images for diagnostic, surgery, and treatment planning purposes, not for direct therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the various analysis extensions (e.g., Advanced Vessel Analysis, CardIQ Analysis, CT Colonography, Advanced Lung Analysis) provide "clinically relevant information for diagnosis, surgery and treatment planning" and "aid trained physicians" in assessment and detection of various medical conditions (e.g., stenosis, cardiovascular disease, polyps, lung abnormalities).
Yes
The device is described as a "software option" and "software package" that provides an interface and advanced analysis capabilities for existing imaging workstations and applications. The description focuses entirely on software functionalities and does not mention any hardware components included with the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this software processes and analyzes medical images acquired from imaging modalities like CT, MR, X-Ray Angio, NM, and PET. These are images of the patient's anatomy, not biological specimens.
- The analysis is performed on imaging data. The software provides tools for visualization, measurement, and analysis of anatomical structures and potential abnormalities within those structures based on the imaging data. This is distinct from analyzing blood, urine, tissue, or other biological samples.
- The output is clinically relevant information for diagnosis, surgery, and treatment planning. While this information is used in the diagnostic process, it is derived from image analysis, not from testing biological samples.
The device falls under the category of medical image processing and analysis software, which is a different regulatory classification than IVDs.
N/A
Intended Use / Indications for Use
Centricity AW Suite is an optional software package that provides an interface between the Centricity PACS Workstation and Volume Viewer such that both applications can run on a single platform while maintaining common patient & exam context. Optional advanced analysis extensions of the Volume Viewer application include: AutoBone, Advanced Vessel Analysis, CT Colonography, CardIQ Analysis, and Advanced Lung Analysis.
Volume Viewer allows the processing, review, analysis and communication of 3D reconstructed images and their relationship to originally acquired images from CT, MR, X-Ray Angio, NM and PET Scanning devices. The combination of acquired images, reconstructed images, annotations and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information for diagnosis, surgery and treatment planning.
Advanced Vessel Analysis can be used in the analysis of 3D angiography data. It provides a number of display, measurement and batch archive features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization.
CardIQ Analysis allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionality for 20/30 rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician to process, render, review, archive and visualize cardiac anatomy and coronary vessels.
CT Colonography allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 2D. 3D and 360 dissection views, and an object oriented endoluminal display. In comparison to Colonoscopy, this tool has an advantage of depth penetration due to its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive and distribute colon image studies.
AutoBone is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data.
Advanced Lung Analysis is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lesions, etc.) from a set of Computed Tomography (CT) images. The software is designed to support the physician in confirming the presence of physician identified lung lesions (e.g. nodules). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. ALA software allows andlysis and displays statistics for nodule characterization all the different nodule types. ALA optional Digital Contrast Agent (DCA) module is an automated highlight feature for the visual identification of possible lesions. Digital Contrast Agent (DCA) is a 3D filter that produces images that highlight spherical (S) and cylindrical (C) anatomical regions, such as nodules, cysts, scars, and vessels. Images are made available to the physician to aid in characterization of suspicious nodules and thus, the patient management care decision process. ALA provides additional information to the physician and is intended to compliment diagnosis based on classical techniques.
Product codes
LLZ
Device Description
Centricity AW Suite is a software option that provides an interface between the Centricity Workstation (on a Windows platform) and Volume Viewer with advanced analysis options such that both these applications can run on a single platform while maintaining common patient and exam context.
Volume Viewer is a previously FDA cleared image analysis software option. Optional advanced analysis extensions of the Volume Viewer application have been previously cleared by FDA and include AutoBone, Advanced Vessel Analysis, CT Colonography, CardiQ Analysis and Advanced Lung Analysis.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, X-Ray Angio, NM, PET
Anatomical Site
Heart, Colon, Abdominal, Extremity, Lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician, referring physician, Radiologists
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 Centricity PACS System complies with the voluntary standards as detailed in Section 12 Specific Standards and Guidance. The following quality assurance measures were applied to the development of the Centricity AW Suite Option:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Final acceptance testing (Validation)
- Performance testing
- Safety testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043415, K993792, K042694, K031871, K041267, K041270, K041521
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
K06 1372
MAY 3 0 2006
Section 2 510(k) Summary of Safety and Effectiveness
| Date: | May 4, 2006 |
|---|---|
| Submitter: | GE Healthcare Information Technologies |
| 540 W Northwest Highway | |
| Barrington, IL 60010 | |
| Contact Person: | Karen M. Lunde |
| Sr. Regulatory Affairs Leader | |
| GE Healthcare Information Technologies | |
| Phone: (847) 277-6092 | |
| Fax: (414) 755-0655 | |
| Device: | |
| Trade Name: | Centricity® AW Suite Option |
| Common/Usual Name: | Picture Archiving and Communications Systems and Workstation |
| Classification Names: | The Centricity PACS is classified as: |
| 21 CFR 892.2050 System, Image Processing, Radiological | |
| The predicate advanced applications are classified as: | |
| 21 CFR 892.1750 Computed Tomography X-ray System (accessory to) | |
| Predicate Device: | K043415 Centricity PACS System |
| K993792: Smart Vessel Analysis Option | |
| K042694: Advanced Lung Analysis II Option | |
| K031871: AutoBone Option | |
| K041267: Card IQ Analysis III Option | |
| K041270: CT Colonography II Option | |
| K041521: Volume Viewer Plus Option | |
| Device Description: | Centricity AW Suite is a software option that provides an interface between |
| the Centricity Workstation (on a Windows platform) and Volume Viewer | |
| with advanced analysis options such that both these applications can run | |
| on a single platform while maintaining common patient and exam context. |
Volume Viewer is a previously FDA cleared image analysis software option.
Optional advanced analysis extensions of the Volume Viewer application
have been previously cleared by FDA and include AutoBone, Advanced
Vessel Analysis, CT Colonography, CardiQ Analysis and Advanced Lung
Analysis. |
| Intended Use: | Centricity AW Suite is an optional software package that provides an
interface between the Centricity PACS Workstation and Volume Viewer
such that both applications can run on a single platform while maintaining
common patient & exam context. Optional advanced analysis extensions of
the Volume Viewer application include: AutoBone, Advanced Vessel
Analysis, CT Colonography, CardIQ Analysis, and Advanced Lung Analysis.
Volume Viewer allows the processing, review, analysis and communication
of 3D reconstructed images and their relationship to originally acquired
images from CT, MR, X-Ray Angio, NM and PET Scanning devices. The
combination of acquired images, reconstructed images, annotations and
measurements performed by the clinician are intended to provide to the
referring physician clinically relevant information for diagnosis, surgery and
treatment planning.
Advanced Vessel Analysis can be used in the analysis of 3D angiography
data. It provides a number of display, measurement and batch archive |
1
features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization.
CardIQ Analysis allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionality for 20/3D rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician to process, render, review, archive and visualize cardiac anatomy and coronary vessels.
CT Colonography allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 2D, 3D and 360 dissection views, and an object oriented endoluminal display. In comparison to Colonoscopy, this tool has an advantage of depth penetration due to its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive and distribute colon image studies.
AutoBone is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data.
Advanced Lung Analysis is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lesions, etc.) from a set of Computed Tomography (CT) images. The software is designed to support the physician in confirming the presence or absence of physician identified lung lesions (e.g. nodules). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. ALA software allows analysis and displays statistics for nodule characterization all the different nodule types. ALA optional Digital Contrast Agent (DCA) module is an automated highlight feature for the visual identification of possible lesions. Digital Contrast Agent (DCA) is a 3D filter that produces images that highlight spherical (S) and cylindrical (C) anatomical regions, such as nodules, cysts, scars, and vessels. Images are made available to the physician to aid in characterization of suspicious nodules and thus, the patient management care decision process. ALA provides additional information to the physician and is intended to compliment diagnosis based on classical techniques.
- The Centricity AW Suite Option employs the same functional scientific Technology: technology as its predicate devices.
- The subject of this 510k is a software option for the Centricity PACS Test Summary: workstation. The Centricity PACS System complies with the voluntary standards as detailed in Section 12 Specific Standards and Guidance. The following quality assurance measures were applied to the development of the Centricity AW Suite Option:
- Risk Analysis .
- Requirements Reviews .
- Design Reviews .
2
- Testing on unit level (Module verification) ●
- Integration testing (System verification) .
- . Final acceptance testing (Validation)
- Performance testing .
- Safety testing .
GE considers features of the Centricity AW Suite Option equivalent to those Conclusion: of the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird-like figure.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 3 0 2006
GE Healthcare Information Technologies % Ms. Elizabeth Drew Senior Project Engineer/510(k) Reviewer Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA 95131
Re: K061372
Trade/Device Name: Centricity AW Suite Option Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 16, 2006 Received: May 17, 2006
Dear Ms. Drew:
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 shows a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906 - 2006" are printed. Below the letters, the word "Centennial" is printed in a cursive font. The logo is surrounded by text that reads "United in Commitment to Consumer Protection & Health Through the Science of Food."
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 (OS) 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology). | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Ko61372
Page 1 of 1
510(k) Number (if known): Unknown;
510(k) filed on May 4, 2006
Device Name: Centricity® AW Suite Option
Indications for Use:
Centricity AW Suite is an optional software package that provides an interface between the Centricity PACS Workstation and Volume Viewer such that both applications can run on a single platform while maintaining common patient & exam context. Optional advanced analysis extensions of the Volume Viewer application include: AutoBone, Advanced Vessel Analysis, CT Colonography, CardIQ Analysis, and Advanced Lung Analysis.
Volume Viewer allows the processing, review, analysis and communication of 3D reconstructed images and their relationship to originally acquired images from CT, MR, X-Ray Angio, NM and PET Scanning devices. The combination of acquired images, reconstructed images, annotations and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information for diagnosis, surgery and treatment planning.
Advanced Vessel Analysis can be used in the analysis of 3D angiography data. It provides a number of display, measurement and batch archive features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization.
CardIQ Analysis allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionality for 20/30 rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician to process, render, review, archive and visualize cardiac anatomy and coronary vessels.
CT Colonography allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 2D. 3D and 360 dissection views, and an object oriented endoluminal display. In comparison to Colonoscopy, this tool has an advantage of depth penetration due to its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive and distribute colon image studies.
AutoBone is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data.
Advanced Lung Analysis is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lesions, etc.) from a set of Computed Tomography (CT) images. The software is designed to support the physician in confirming the presence of physician identified lung lesions (e.g. nodules). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. ALA software allows andlysis and displays statistics for nodule characterization all the different nodule types. ALA optional Digital Contrast Agent (DCA) module is an automated highlight feature for the visual identification of possible lesions. Digital Contrast Agent (DCA) is a 3D filter that produces images that highlight spherical (S) and cylindrical (C) anatomical regions, such as nodules, cysts, scars, and vessels. Images are made available to the physician to aid in characterization of suspicious nodules and thus, the patient management care decision process. ALA provides additional information to the physician and is intended to compliment diagnosis based on classical techniques.
6
K061372
Page 2 of 2
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ X (Per 21 CFR 801.109)
.
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
.
(Optional Format 1-2-96)
Daniel A. Benson
OR
(Division Sign Division of F and Radio 510(k) Nu
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