NORDICICE SOFTWARE

K082441 · Nordicimaginglab AS · LLZ · Nov 21, 2008 · Radiology

Device Facts

• Record ID: K082441
• Device Name: NORDICICE SOFTWARE
• Applicant: Nordicimaginglab AS
• Product Code: LLZ · Radiology
• Decision Date: Nov 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis. BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity. DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain. Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time where such techniques are useful or necessary.

Device Story

nordicICE is a medical image viewing, analysis, and processing software package. It accepts DICOM-compliant imaging data, primarily from MRI systems. The software operates on standard off-the-shelf Windows PC workstations. Imaging professionals use the software to perform BOLD fMRI analysis (highlighting magnetic susceptibility changes related to neuronal activity), DWI/fiber tracking (visualizing water diffusion and white matter structure), and dynamic analysis (evaluating contrast changes over time). The software provides visual displays and quantitative analysis of these datasets. Clinicians use these outputs to visualize brain function and structure, aiding in clinical decision-making. The device benefits patients by providing advanced visualization and analysis of complex functional and dynamic MRI datasets.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Software-based image processing package. Operates on standard off-the-shelf Windows PC workstations. Inputs via DICOM-compliant imaging modalities. Functionality includes BOLD fMRI analysis, DWI/fiber tracking, and dynamic imaging analysis.

Indications for Use

Indicated for use by trained professionals (physicians, medical technicians) to view, process, and analyze medical images (primarily MRI) acquired via DICOM-compliant modalities. Includes BOLD fMRI for brain blood-flow analysis, DWI/fiber tracking for white matter structure visualization, and dynamic analysis for contrast-over-time imaging.

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

• Nordic Image Control and Evaluation (nordicICE) Software (K063539)

Submission Summary (Full Text)

{0}------------------------------------------------

KOr241//

# 510(k) Summary

NOV 21 2008

| 510(k) Type: | Traditional |
|------------------|-------------------------------------------------------------------------------------|
| Submission Date: | 08.22.2008 |
| Submitter: | NordicImagingLab AS<br>Møllendalsveien 65C<br>N-5009 Bergen<br>Norway |
| | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Contact: | Stian Scisly Sagevik<br>Møllendalsveien 65C<br>N-5009 Bergen<br>Norway |
| | Direct: [phone]<br>Phone: [phone] |

Predicate device name and 510(k) number: Nordic Image Control and Evaluation (nordiclCE) Software, коезезд

.

.

| Trade/Proprietary Name: | nordicICE Software |
|----------------------------|--------------------|
| Device Common Name: | PACS |
| Classification Regulation: | 892.2050 |
| Class: | II |
| Panel: | Radiology |
| Product Code: | LLZ |

Fax:

[phone] Email: [e-mail]

-

{1}------------------------------------------------

## Device Description

nordiclCE (nlCE) - Nordic Image Control and Evaluation software - is a medical viewing, analysis, and processing package developed with a view to ease of use and high performance on a standard Windows platform. The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive functionality for dynamic image analysis and processing/display of functional MRI (fMRI) data. The main user of the program will be imaging professionals who need to visualize and analyze images taken primarily from a MRI system.

### Intended Use

nordiclCE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.

BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity.

DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain.

Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time where such techniques are useful or necessary.

### Substantial Equivalence

nordicICE has been verified and validated according to NIL's procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by nordicICE was found to be substantially equivalent with the predicate device Nordic Image Control and Evaluation (nordicICE) Software (K063539).

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### NOV 21 2008

Ms. Stian Scisly Sagevik Quality Manager NordicimagingLab AS Møllendalsveien 65C N-5009 Bergen NORWAY

Re: K082441

Trade/Device Name: Nordic Image Control and Evaluation (nordicICE) Software Regulation Number: 21 CFR 892.2050

Regulation Name: Picture archiving and communications system

Regulatory Class: II

Product Code: LLZ

Dated: September 24, 2008

Received: October 14, 2008

Dear Ms. Sagevik:

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 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.

{3}------------------------------------------------

#### Page 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 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

hoque Mr. Whang

Joyce M. Whang, Ph.D. Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known):

Device Name: Nordic Image Control and Evaluation (nordicICE) Software

Indications for Use:

nordic!CE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.

BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity.

DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain.

Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time where such techniques are useful or necessary.

Prescription Use_ X (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 OF NEEDED)

| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|--------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal and Radiological Devices | |
| NordicImagingLab AS – Special 510(k) | |
| 510(k) Number | K082441 |
| Indications for Use | |
| nordicICE Software | |
| Attachment 2 | |