COR ANALYZER II, MODEL V1.7

K072242 · Rcadia Medical Imaging , Ltd. · LLZ · Sep 11, 2007 · Radiology

Device Facts

• Record ID: K072242
• Device Name: COR ANALYZER II, MODEL V1.7
• Applicant: Rcadia Medical Imaging , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Sep 11, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

COR Analyzer II is a post-processing software application for stand-alone Windows workstations. It accepts Computed Tomography Angiography (CTA) images as input. The operator reviews and selects data for processing. The software performs coronary artery tree segmentation, labels arteries, and displays them in a 3D view with unique coloring. It processes artery volume changes to detect deviations from expected values; detected deviations exceeding a threshold are highlighted on the 3D display. Used in clinical settings by physicians to assist in visualizing coronary anatomy and pathology. The output aids clinical decision-making by providing automated segmentation and abnormality detection, potentially benefiting patients through improved visualization of coronary lesions.

Clinical Evidence

Bench and clinical data demonstrate that the COR Analyzer II meets required specifications. No adverse effects detected. Design verified and validated per 21 CFR 820.30.

Technological Characteristics

Post-processing software application; runs on stand-alone Windows-based workstation; inputs CTA image sets; performs coronary artery tree segmentation, labeling, and 3D visualization; detects volume deviations exceeding thresholds.

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/processing. Not for mammography.

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)
• COR Analyzer I (K063548)

Submission Summary (Full Text)

{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: [phone]

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 [phone] or [phone]

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