(14 days)
Not Found
No
The document describes standard image processing and measurement tools without mentioning AI, ML, or related concepts like deep learning or neural networks.
No
The device is a post-processing software that aids physicians in visualizing and assessing cardiac anatomy and coronary vessels; it does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section states that the product "can be used to aid trained physicians for visualizing and assessing cardiac anatomy, and coronary vessels," and "for the assessment of plaque densities with the coronary arteries." The device also provides measurements like vessel diameter and Hounsfield Units, which are used in diagnosis.
Yes
The device is described as a "post processing software option" for an existing workstation platform and its function is solely image analysis and measurement, indicating it is a software-only component.
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 (like blood, urine, tissue) to provide information about a person's health.
- CardIQ Analysis II's function: CardIQ Analysis II is a software that analyzes imaging data (CT angiography images) of the heart and coronary arteries. It does not perform tests on biological samples.
- Intended Use: The intended use is for visualizing and assessing cardiac anatomy and coronary vessels based on imaging, not on laboratory test results.
Therefore, CardIQ Analysis II falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CardIQ Analysis II is a post processing software option for Advantage Windows Workstation (AW) Platform. This product can be used for the analysis of CT angiography images and for the assessment of plaque densities with the coronary arteries. It provides a number of display, measurement and batch filming features. The product can be used to aid trained physicians for visualizing and assessing cardiac anatomy, and coronary vessels.
Product codes
90 JAK
Device Description
CardIQ Analysis II is a post processing software option that can be used in the analysis of CT angiography images to display structures of the heart in a MIP, reformat or volume rendering view. The software has the ability to measure the diameter of the vessel, Hounsfield Units within connay arteries, or plaque density within a vessel. Measurements, densities and images can all be priced to reports or saved to the AW workstation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT angiography images
Anatomical Site
Heart, cardiac anatomy, coronary vessels, coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physicians
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows a date, "MAR 2 6 2002". The month is March, the day is the 6th, and the year is 2002. The text is in a bold, sans-serif font.
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters and the circle are depicted in black, creating a strong contrast against the white background. The logo is a well-known symbol associated with the General Electric company.
(8)
GE Medical Sv General Electric Company P O Box 414 Milwaukee, WI 53201
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 Program Manager Telephone: (262) 544-3894, FAX: (262) 544-3863 Date Prepared: February 8, 2002
PRODUCT IDENTIFICATION
| Name: | CardIQ Analysis II |
|---|---|
| Classification Name: | Accessory to Computed Tomography System |
| Classification Panel: | 892 - Radiology |
| Classification Number: | 892.1750 |
| Manufacturer : | General Electric Medical Systems |
| 283, rue de la Miniere | |
| 78533 Buc Cedex, FRANCE | |
| Distributor: | General Electric Medical Systems, Milwaukee, WI |
| Marketed Devices | CardIQ Analysis II is substantially equivalent to the device listed below: |
| Model: | CardIQ Option 1.0 |
| Manufacturer: | General Electric Medical Systems, Milwaukee, WI |
| 510(k) #: | K003408 |
Device Description:
CardIQ Analysis II is a post processing software option that can be used in the analysis of CT angiography images to display structures of the heart in a MIP, reformat or volume rendering view. The software has the ability to measure the diameter of the vessel, Hounsfield Units within connay arteries, or plaque density within a vessel. Measurements, densities and images can all be priced to reports or saved to the AW workstation.
1
Indications for Use:
CardIQ Analysis II is a post processing software option for Advantage Windows Workstation (AW) Platform. This product can be used for the analysis of CT angiography images and for the assessment of plaque densities with the coronary arteries. It provides a number of display, measurement and batch filming features. The product can be used to aid trained physicians for visualizing and assessing cardiac anatomy, and coronary vessels.
Comparison with Predicate:
CardIQ Analysis II is a software option for CT Scanners. Features of this software package are substantially equivalent to the following device:
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Adverse Effects on Health :
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.
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· Adherence to industry and international standards.
Conclusions:
CardIQ Analysis II does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the CardIO Analysis II to be equivalent to those of CT CardIQ Option 1.0 (K003408).
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wings, symbolizing strength and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and governmental nature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2002
General Electric Medical Systems % Mr. Wolfram Gmelin Technical Manager TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K020796
Trade/Device Name: Card IQ Analysis II CT Scanner Post-Processing Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: February 1, 2002 Received: March 12, 2002
Dear Mr. Gmelin:
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); 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.
3
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
4
STATEMENT OF INTENDED USE
510(k) Number (if known): _ Ko 2 079 6 _______________________________________________________________________________________________________________________________________
Device Name: CardIQ Analysis II
Indications For Use:
CardIQ Analysis II is a post processing software option for Advantage Windows Workstation (AW) Platform. This product can be used for the analysis of CT angiography images and for the assessment of plaque densities with the coronary arteries. It provides a number of display, measurement and batch filming features. The product can be used to aid trained physicians for visualizing and assessing cardiac anatomy, and coronary vessels.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | -OR- | Over-The-Counter Use | ||
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
Nancy C. Brogdon
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K020796 |