NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1

K063539 · Nordicicemedical AS · LLZ · Jan 17, 2007 · Radiology

Device Facts

• Record ID: K063539
• Device Name: NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1
• Applicant: Nordicicemedical AS
• Product Code: LLZ · Radiology
• Decision Date: Jan 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Nordic Image Control and Evaluation (nICE) Software is an image management system intended to be used by trained professionals, including but not limited to physicians. nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

Device Story

nICE Software is a medical imaging manipulation tool for clinical environments; operates on Windows-based general-purpose computing hardware. Inputs consist of medical radiographic images and data from DICOM-compliant imaging devices. The software provides tools for clinicians to view, optimize, read, define, share, and report on these images. By facilitating efficient image management and manipulation, the device supports clinician workflow and diagnostic decision-making. It is intended for use by physicians, nurses, and medical technicians.

Clinical Evidence

Bench testing only. Prospectively defined verification and validation activities were conducted to ensure the software meets design and performance specifications and user needs.

Technological Characteristics

Medical imaging software for Windows operating systems. Functions as a PACS (Picture Archiving and Communication System). Supports DICOM-compliant image acquisition, transmission, processing, and storage. Operates on general-purpose computing hardware.

Indications for Use

Indicated for use by trained professionals (physicians, nurses, medical technicians) as an image management system for acquiring, transmitting, processing, and storing DICOM-compliant medical images and data in clinical environments. Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images.

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

• eFILM Workstation with Modules (K020995)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains handwritten text that appears to be a code or identifier. The text reads "Kol 3534". The numbers are written in a slightly stylized manner, and the overall impression is that of a handwritten label or notation.

JAN | 7 2007

:

## SECTION 5

## 510(K) SUMMARY

NordicIceMedical AS - Traditional 510(k) nICE Software

:

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# 510(k) Summary NordicIceMedical AS Nordic Image Control and Evaluation (nICE) Software

#### COMPANY NAME AND ADDRESS 1.

#### 1.1 Sponsor

NordicIceMedical AS
Mollendalsvein 61A
5008 Bergen
Norway

| Telephone: | [phone] |
|------------|--------------|
| Fax: | [phone] |

Primary Contact: Tormod Thomsen ([e-mail])

### Please be advised that effective December 1, 2006, NordicIceMedical AS will change its name to NordicImagingLab AS.

#### 2. DEVICE NAME

| Proprietary Name: | Nordic Image Control and Evaluation (nICE) Software |
|----------------------|-----------------------------------------------------|
| Common/Usual Name: | PACS |
| Device | System, image processing, radiological |
| Classification Name: | Picture archiving and communication system |
| Product Code | LLZ |
| 21 VFR Regulation | 892.2050 |

#### 3. PREDICATE DEVICE

eFILM Workstation with Modules, K020995, Merge eMED. Inc.

#### DEVICE DESCRIPTION 4.

Nordic Image Control and Evaluation (nICE) Software is a medical imaging manipulation tool, designed to provide a way to optimize the clinician's workflow. It targets activities fundamental to their work: reading, defining, sharing and reporting medical radiographic images. It is designed to work within a Windows™ operating system, and provides the user with the ability to view a wide range of image types.

.

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#### INTENDED USE 5.

Nordic Image Control and Evaluation (nICE) Software is an image management system intended to be used by trained professionals, including but not limited to physicians. nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The nICE Software is substantially equivalent to the eFILM Workstation with Modules (K020995) in intended use, indications for use, technological characteristics and operational characteristics.

#### 7. PERFORMANCE TESTING

Prospectively defined verification and validation activities for the nICE Software assure that the nICE Software is substantially equivalent to the cleared eFILM Workstation with Modules and meets design and performance specifications as well as user needs when operated according to the operating instructions.

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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with three flowing lines above it, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

NordicleeMedical AS % Mr. James W. Knox Senior Regulatory Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

JAN 1 7 2007

Re: K063539

Trade/Device Name: Nordic Image Control and Evaluation (nICE) Software version 2. l Regulation Number: 21 CFR 892.2050

Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ

Dated: November 22, 2006 Received: November 27, 2006.

Dear Mr. Knox:

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/3/Picture/12 description: The image is a circular logo with the text "1906-2006" at the top. Below the text is a large "FDA" in bold letters. Underneath "FDA" is the word "Centennial" in a cursive font. There are three stars at the bottom of the logo. The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.

Protecting and Promoting Public Health

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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" (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.l1tml.

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

Enclosure

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### Indications for Use

510(k) Number (if known): Ku (3539

Device Name: Nordic Image Control and Evaluation (nICE) Software version 2.1

Indications For Use:

Nordic Image Control and Evaluation (nICE) Software is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brygdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

NordiciceMedical AS - Traditional 510(k) nICE Software

510(k) Number .