(59 days)
K061624 Vitrea2
Not Found
No
The summary describes standard image processing techniques and user interaction for vessel analysis, with no mention of AI, ML, or related concepts.
No
The device is a software application that processes and visualizes CT angiographic images to assist physicians in analyzing coronary vessels and lesions. It does not directly treat or diagnose a disease but rather aids in the diagnostic process.
Yes
Explanation: The device is intended to "assist a trained physician to analyze Computed Tomography (CT) Angiographic images" and "provide visualization of the major coronary vessels and lesions, thus assisting the physician in visualizing the coronary anatomy and pathology." This clearly indicates its role in helping diagnose conditions related to coronary vessels.
Yes
The device description explicitly states that COR Analyzer I is a "post processing software application which runs on a stand-alone Windows based work-station." It processes existing image data and does not include any hardware components.
Based on the provided information, the COR Analyzer I is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- COR Analyzer I Function: The COR Analyzer I processes and analyzes medical images (Computed Tomography Angiography - CTA) taken from the human body. It does not analyze biological specimens.
- Intended Use: The intended use is to assist a physician in analyzing CT angiographic images for visualization of coronary vessels and lesions. This is image analysis, not laboratory testing of biological samples.
Therefore, the COR Analyzer I falls under the category of a medical image processing software or a radiology device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The COR Analyzer I is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The COR Analyzer I 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 I has abilities for coronary vessels segmentations, abnormalities display and processing.
Product codes (comma separated list FDA assigned to the subject device)
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. The application enables interactive user-software process in which the user chooses a CT slice, points on the selected coronary vessel and the software present the entire selected vessel as a stretched image. In a reversed process, the user can mark a specific point on the stretched vessel and the software retrieves and displays the original correspondent CT slice. COR Analyzer I output results can be stored for future analysis.
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
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 I meets the required specifications. No adverse affects have been detected.
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.
K061624 Vitrea2
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).
0
Kob3548
510(k) Summary
.
JAN 2 2 2007
1
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b))
Device Name
Proprietary Device Name:COR Analyzer I
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
Device Classification
| Product Code: | LLZ |
|---|---|
| Regulation Number: | 892.2050 |
| Common Name: | PACS - Picture archiving &communications system |
| Classification Name: | Picture archiving and communications system |
| Regulatory class: | Class II |
Reason for 510(k) Submission
Traditional 510(k) Submission
Identification of Legally Marketed Equivalent Devices
K061624 Vitrea2
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. The application enables interactive user-software process in which the user chooses a CT slice, points on the selected coronary vessel and the software present the entire selected vessel as a stretched image. In a reversed process, the user can mark a specific point on the stretched vessel and the software retrieves and displays the original correspondent CT slice. COR Analyzer I output results can be stored for future analysis.
Indications for use
The COR Analyzer I is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The COR Analyzer I 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 I 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 I meets the required specifications. No adverse affects have been detected.
Substantial Equivalency
It is Rcadia Medical Imaging Ltd. opinion that the COR Analyzer I is substantially equivalent in terms of safety and effectiveness to the predicate device.
2
Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol consists of three curved lines that resemble a stylized human figure or a flowing design. The text is arranged around the perimeter of the circle, and the symbol is positioned in the center.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JAN 2 2 2007
Mr. Dan Laor Official Correspondent Rcadia Medical Imaging Ltd. Derech Yafo 157 Haifa, 35251 ISRAEL
Re: K063548
Trade/Device Name: COR Analyzer I Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: LLZ and JAK Dated: November 20, 2006 Received: November 24, 2006
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 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/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged beneath the word "Centennial".
Protecting and Promoting Public Health
3
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.
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. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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