COR ANALYZER 1, VERSION 1.4

K063548 · Rcadia Medical Imaging , Ltd. · LLZ · Jan 22, 2007 · Radiology

Device Facts

• Record ID: K063548
• Device Name: COR ANALYZER 1, VERSION 1.4
• Applicant: Rcadia Medical Imaging , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jan 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

COR Analyzer I is post-processing software for stand-alone Windows workstations; inputs are Computed Tomography Angiography (CTA) images. Operator selects CT slices and points on coronary vessels; software performs vessel segmentation and generates stretched vessel images. Reverse process allows mapping points from stretched images back to original CT slices. Used by physicians in clinical settings to visualize coronary anatomy and pathology; output stored for future review. Assists clinical decision-making by providing enhanced visualization of vessels and lesions; benefits patient through improved anatomical assessment.

Clinical Evidence

Bench and clinical data provided; device designed, verified, and validated per 21 CFR 820.30. No adverse effects reported.

Technological Characteristics

Post-processing software application; runs on stand-alone Windows-based workstation. Features include coronary vessel segmentation, abnormality display, and image processing. Connectivity via standard workstation environment.

Indications for Use

Indicated for trained physicians to analyze CT Angiographic images for visualization of major coronary vessels and lesions, including coronary vessel segmentation and abnormality display.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Vitrea2 (K061624)

Submission Summary (Full Text)

{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: [phone]

## 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 [phone] or [phone]

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

{4}------------------------------------------------

# Indications for Use

< 063548

510(k) Number (if known): K (3 (3 5 4 8

Device Name: COR Analyzer I

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.

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 1

Daniel A. Serrano

(Division Sign-Off) and Read Polyn-Off)
Division of Reproductive, Abdominal,
and Radiological Devices and Radiological Devices 510(k) Number