(29 days)
No
The summary describes image processing and segmentation techniques but does not mention AI, ML, or related terms like neural networks or deep learning. The description of the processing steps aligns with traditional image analysis methods.
No
The device is intended to assist a physician in analyzing images and visualizing anatomy and pathology; it does not directly treat or diagnose a disease or condition.
Yes
The device is intended to assist physicians in analyzing CT Angiographic images to visualize coronary vessels and lesions, identify abnormalities, and process deviations, all of which are diagnostic functions.
Yes
The device is described as a "post processing software application which runs on a stand-alone Windows based work-station" and its input is "Computed Tomography Angiography (CTA) set of images." It performs analysis and visualization of these images. There is no mention of hardware being part of the device itself, only the workstation it runs on, which is a general-purpose computing platform.
Based on the provided information, the COR Analyzer II is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The COR Analyzer II processes images (Computed Tomography Angiography images) of the human body, not biological samples like blood, urine, or tissue.
- The intended use is to assist a physician in analyzing images. This is a function of medical image processing and analysis, not laboratory testing of biological specimens.
- The device description focuses on image processing and visualization. It describes segmenting vessels, displaying them in 3D, and detecting deviations based on volume changes, all of which are image-based operations.
In summary, the COR Analyzer II is a medical image analysis software, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The COR Analyzer II is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The device is not intended for use with mammography. The COR Analyzer II is specifically indicated to provide visualization of the major coronary vessels and lesions, thus assisting the physician in visualizing the coronary anatomy and pathology. COR Analyzer II has abilities for coronary vessels segmentations, abnormalities display and processing.
Product codes
LLZ, JAK
Device Description
COR Analyzer I is a post processing software application which runs on a stand-alone Windows based work-station. The device input is Computed Tomography Angiography (CTA) set of images. The received data is displayed on the workstation screen, reviewed and selected by the operator for processing. Software provides the location and segmentation of the coronary artery tree. The software also labels the coronary arteries and displays them uniquely colored in a 3D view. The artery changes of volumes are processed and deviations from expected values are detected. When a deviation exceeds threshold value it is displayed on the 3D view.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography Angiography (CTA)
Anatomical Site
coronary vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
a trained physician
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 device has been designed, verified and validated complying with 21CFR 820.30 regulations. Bench and clinical data demonstrate that the COR Analyzer II meets the required specifications. No adverse affects have been detected.
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).
0
KO72242
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Device Name
Proprietary Device Name:COR Analyzer II
Establishment Name and Registration Number of Submitter
Name: RCADIA Ltd. (RCADIA hereafter) Registration: In process Submission contact: Dan Laor Sireni 6, Haifa 32972, Israel TEL: 972-4-8246632
SEP 1 1 2007
Device Classification
Product Code: Subsequent Product Code: Regulation Number: Common Name: Classification Name: Regulatory class:
LLZ JAK 892.2050 PACS - Picture archiving &communications system Picture archiving and communications system Class II
Reason for 510(k) Submission
Special 510(k) Submission
Identification of Legally Marketed Equivalent Devices
K061624 Vitrea2, K063548 COR Analyzer I
Device Description
COR Analyzer I is a post processing software application which runs on a stand-alone Windows based work-station. The device input is Computed Tomography Angiography (CTA) set of images. The received data is displayed on the workstation screen, reviewed and selected by the operator for processing. Software provides the location and segmentation of the coronary artery tree. The software also labels the coronary arteries and displays them uniquely colored in a 3D view. The artery changes of volumes are processed and deviations from expected values are detected. When a deviation exceeds threshold value it is displayed on the 3D view.
Indications for use
The COR Analyzer II is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The device is not intended for use with mammography. The COR Analyzer II is specifically indicated to provide visualization of the major coronary vessels and lesions, thus assisting the physician in visualizing the coronary and pathology. COR Analyzer II has abilities for coronary vessels segmentations, abnormalities display and processing.
Safety & Effectiveness
The device has been designed, verified and validated complying with 21CFR 820.30 regulations. Bench and clinical data demonstrate that the COR Analyzer II meets the required specifications. No adverse affects have been detected.
Substantial Equivalency
It is Rcadia Medical Imaging Ltd. opinion that the COR Analyzer II is substantially equivalent in terms of indications for use, safety and effectiveness to the predicate devices.
1
Image /page/1/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized symbol that resembles three abstract figures or lines, possibly representing people or services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
RCADIA Medical Imaging, Ltd. % Mr. Dan Laor Managing Director Quasar Quality Ltd. 6 Sireni Haifa Israel 32972
SEP 1 1 2007
Re: K072242
Trade/Device Name: COR Analyzer II Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 12, 2007 Received: August 13, 2007
Dear Mr. Laor:
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 indivers 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 Cornein Act (Act) that do not require approval of a premarket approval application (PMA). You COSU, therefore, market the device, subject to the general controls provisions of the Act, Tho 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, FFA may publish further announcements concerning your device in the Federal Reegister.
Image /page/1/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, "Centennial" at the bottom, and the letters "FDA" in the center. There are three stars below the word "Centennial". The logo appears to be a commemorative emblem for the centennial anniversary of the FDA.
oting Publio Hoalth ralating and OP
2
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 not his act or any Federal statutes and regulations administered by other Federal agencies. Your 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.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Nancy C Hodgon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Image /page/2/Picture/10 description: The image contains the word "Enclosure" in a simple, sans-serif font. The text is black and appears to be isolated against a white background. The word is presented in a straightforward manner, with no additional design elements or context provided.
3
Indications for Use
510(k) Number (if known):
Device Name: COR Analyzer II
Indications For Use:
The COR Analyzer II is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The device is not intended for use with mammography. The COR Analyzer II is specifically indicated to provide visualization of the major coronary vessels and lesions, thus assisting the physician in visualizing the coronary anatomy and pathology. COR Analyzer II has abilities for coronary vessels segmentations, abnormalities display and processing.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Page 1 of
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number