(13 days)
Not Found
No
The summary describes image processing and fusion software, but does not mention AI, ML, or related concepts like deep learning or neural networks.
No.
The device is a software post-processing package that analyzes medical images to aid in diagnosis and treatment planning, but it does not directly apply or provide therapy.
Yes
Explanation: The device is intended to "analyze vascular anatomy and pathology," "aid in the assessment of functional data," and "aid in tailoring treatment plans." It provides tools for "sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a vessel, measure areas of abnormalities within a vessel (like stenosis, plaque)." These functions are indicative of a diagnostic purpose.
Yes
The device is described explicitly as a "software post-processing package" and an "additional tool for the analysis" of existing imaging data. It does not include or require any specific hardware components beyond the platforms it runs on (AW platform, PET/CT and CT scanners, PACS reading stations), which are themselves medical devices that generate the input data. The function is purely analytical and visualization based on pre-existing images.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- CardIQ Fusion's Function: CardIQ Fusion is a software post-processing package that analyzes medical images (CT, PET, SPECT) of the heart and its vasculature. It does not analyze biological samples taken from the patient. Its purpose is to visualize, measure, and fuse existing imaging data to aid clinicians in diagnosis and treatment planning.
Therefore, CardIQ Fusion falls under the category of medical imaging software or a medical image analysis device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CardIQ Fusion is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology, aid in the assessment of functional data e.g. PET perfusion, and aid in tailoring treatment plans based on the fused anatomical and functional information. Anatomical data could be from a set of Computed Tomography (CT) Angiographic images while functional data could be from PET, SPECT, or processed CT data.
CardIQ Fusion is a software post-processing package for the Advantage Workstation (AW) platform, PET/CT and CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic cardiac images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally, it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information.
With CardIQ Fusion, clinicians have the opportunity to overlay functional information over the (CT) anatomy of a patient's heart, and thus, they can potentially tailor their decision for that particular patient. CardIQ Fusion provides the visualization of the vessels in several different formats including 3D rendering, curved reformats. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a vessel, measure areas of abnormalities within a vessel (like stenosis, plaque).
Functional data could come from PET, SPECT, or processed CT data for perfusion information. The functional and anatomical data could come from the same scanner as in the case of PET/CT scanner; or they could come from separate scanners like stand alone NUC camera and stand alone CT scanner.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
CardIQ Fusion is a post processing analysis software package designed to assist Radiologists, Nuclear Medicine Doctors, Cardiologists, and other clinicians in the evaluation and assessment of heart including its coronary vasculature and perfusion conditions.
CardIQ Fusion is a software post-processing package for the Advantage Workstation (AW) platform, PET/CT and CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic cardiac images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally, it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT) Angiographic images, PET, SPECT, processed CT data
Anatomical Site
Heart, coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists, Nuclear Medicine Doctors, 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)
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.
K041267, K010336, K013422, K060779, K040141
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
MAY 3 0 2006
K061370
Phylof
GE Healthcare
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- Submitter Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager Tel: (262) 544-3894 Fax: (262) 544-3202 GE Healthcare W-440 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: April 19, 2006
PRODUCT IDENTIFICATION
| Name:
Manufacturer: | CardIQ Fusion
Classification Name: Accessory to Computed Tomography System per 21 CFR 892-1750
GE Medical Systems SCS
283, rue de la Minière
78533 Buc Cedex, FRANCE |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Distributor: | GE Healthcare, P.O. Box 414, Milwaukee, WI 53210 |
| Marketed Devices | CardIQ Fusion is substantially equivalent to the devices listed below: |
| Model:
Manufacturer:
Model:
Manufacturer:
Model:
�
Manufacturer: | CardIQ Pro, 510(k) #K041267
GE Medical Systems SCS, Buc, France
CT/PET Fusion, 510(k) # K010336
GE Medical Systems SCS, Buc, France
CardIO Function, 510(k) # K013422
GE Healthcare, 3200 North Grandview Blvd, Waukesha, WI 53188 USA |
| Model:
Manufacturer:
Model:
●
1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | ECToolbox with HeartFusion, 510(k) # K040141
Syntermed, INC, USA
Advanced Vessel Analysis II, 510(k) # K060779
CD Madinal Cristoma CCC Duo Eronoo |
- GE Medical Systems SCS, Buc, France Manufacturer: .
Device Description:
CardIQ Fusion is a post processing analysis software package designed to assist Radiologists, Nuclear Medicine Doctors, Cardiologists, and other clinicians in the evaluation and assessment of heart including its coronary vasculature and perfusion conditions.
CardIQ Fusion is a software post-processing package for the Advantage Workstation (AW) platform, PET/CT and CT scanners and PACS reading stations. It is an additional tool for the
1
Image /page/1/Picture/0 description: The image shows handwritten text. The text at the top appears to be a code or identifier, possibly "K061370". Below this, the text "page 2 of 3" is visible, indicating this is page 2 of a 3-page document. The handwriting is somewhat stylized and the ink is dark, providing clear contrast against the background.
analysis of 3D CT angiographic cardiac images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally, it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information.
Indications for Use:
CardIQ Fusion is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology, aid in the assessment of functional data e.g. PET perfusion, and aid in tailoring treatment plans based on the fused anatomical and functional information. Anatomical data could be from a set of Computed Tomography (CT) Angiographic images while functional data could be from PET, SPECT, or processed CT data.
CardIQ Fusion is a software post-processing package for the Advantage Workstation (AW) platform, PET/CT and CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic cardiac images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally, it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information.
With CardIQ Fusion, clinicians have the opportunity to overlay functional information over the (CT) anatomy of a patient's heart, and thus, they can potentially tailor their decision for that particular patient. CardIQ Fusion provides the visualization of the vessels in several different formats including 3D rendering, curved reformats. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a vessel, measure areas of abnormalities within a vessel (like stenosis, plaque).
Functional data could come from PET, SPECT, or processed CT data for perfusion information. The functional and anatomical data could come from the same scanner as in the case of PET/CT scanner; or they could come from separate scanners like stand alone NUC camera and stand alone CT scanner.
Comparison with Predicate:
CardIO Fusion is substantially equivalent to the predicate devices listed below:
| Device Name | FDA Clearance Number |
|---|---|
| CardIQ Pro | K041267 |
| CT PET Fusion | K010336 |
| CardIQ Function | K013422 |
| AVA II | K060779 |
| ECToolbox with HeartFusion | K040141 |
Adverse Effects on Health:
2
Image /page/2/Picture/0 description: The image shows handwritten text that appears to be a combination of numbers and letters. The text includes "K061370" on the top line, followed by what looks like "page 303" on the second line. The handwriting is somewhat stylized, making it slightly difficult to read some of the characters.
The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:
- · Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
- · Adherence to industry and international standards.
Conclusions:
CardIQ Fusion does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the CardIQ Fusion to be equivalent to those of CardIQ Pro, CT PET Fusion, ECToolbox with HeartFusion, CardIQ Function, and Advanced Vessel Analysis II.
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 body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 3 0 2006
GE Healthcare % Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd, Unit B7 TWINSBURG OH 44087
Re: K061370
Trade/Device Name: CardIQ Fusion Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 16, 2006 Received: May 17, 2006
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) prematice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate winest the use stated in the encrosuly manation date of the Medical Device Amendments, or to devices that proof to May 26, 1770, the chaomistic date the no visions of the Federal Food, Drug, and Cosmetic liave bech recassified in accordines not a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, matter the device, babyer ex- ex- general registration, listing of devices, good Controls provisions of the necessariat misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket IT your device is classified (soc accres) additional controls. Existing major regulations affecting your Apploval), it they be subject to out 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 is a black and white circular logo. The logo commemorates the centennial anniversary from 1906 to 2006. The letters "FDA" are prominently displayed in the center of the logo. The word "Centennial" is written below the letters.
oting Public Healt
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); Habeling (21 CFR Part 801); 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.
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
Indications for Use
510(k) Number (if known): _ K 0 4 137 0
Device Name: CardIQ Fusion
Indications for Use:
ರ
CardIQ Fusion is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology, aid in the assessment of functional data e.g. PET perfusion, and aid in tailoring treatment plans based on the fused anatomical and functional information. Anatomical data could be from a set of Computed Tomography (CT) Angiographic images while functional data could be from PET, SPECT, or processed CT data.
CardIQ Fusion is a software post-processing package for the Advantage Workstation (AW) platform, PET/CT and CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic cardiac images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally, it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information.
With CardIQ Fusion, clinicians have the opportunity to overlay functional information over the (CT) anatomy of a patient's heart, and thus, they can potentially tailor their decision for that particular patient. CardIQ Fusion provides the visualization of the vessels in several different formats including 3D rendering, curved reformats. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a vessel, measure areas of abnormalities within a vessel (like stenosis, plaque),
Functional data could come from PET, SPECT, or processed CT data for perfusion information. The functional and anatomical data could come from the same scanner as in the case of PET/CT scanner; or they could come from separate scanners like stand alone NUC camera and stand alone CT scanner.
Prescription Use Over-The-Counter Use ANDIOR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Dorman
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number_ K061370
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