LCD MONITOR

K140956 · Nordicneurolab · LNH · Aug 7, 2014 · Radiology

Device Facts

• Record ID: K140956
• Device Name: LCD MONITOR
• Applicant: Nordicneurolab
• Product Code: LNH · Radiology
• Decision Date: Aug 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The LCD monitor is intended to be used by trained professionals as an fMRI viewing monitor within the MR environment. This device must not be used for a life support system. This device must not be used for diagnostics.

Device Story

LCD monitor designed for viewing images in MR environment; used by trained professionals. Device receives image data from MRI system; processes via high-performance controller for high-definition display. Used in MR suite to facilitate fMRI viewing. Output allows clinicians to visualize fMRI data during procedures. Benefits include high-quality visualization within the MR environment. Not for diagnostic use or life support.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed device meets design and performance specifications. Safety certified to international standards (IEC 60601-1, IEC 60601-1-2).

Technological Characteristics

High-resolution LCD panel with image processing controller. Designed for MR environment. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for use by trained professionals as an fMRI viewing monitor within the MR environment. Not for use in life support systems or for diagnostic purposes.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• fMRI Hardware System (K092253)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure in profile, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 7, 2014

Nordic NeuroLab AS % Mr. Chandana Gurung Bhandari Mollendalsveien 65 C N-5009 Bergen NORWAY

Re: K140956

Trade/Device Name: LCD Monitor Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 27, 2014 Received: July 7, 2014

Dear Mr. Bhandari:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.Hara
for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) 140956

Device Name LCD Monitor

Indications for Use (Describe) The LCD monitor is intended to be used by trained professionals as a fMRI viewing monitor within the MR environment.

This device must not be used for a life support system. This device must not be used for diagnostics.

Type of Use (Select one or both, as applicable)

∑ Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Michael D'Hara

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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# 510(k) Summary NordicNeuroLab AS NNL Monitor

Submitter: NordicNeuroLab AS Møllendalsveien 65C N-5009 Bergen Norway Phone: [phone] Fax: [phone]

Primary Contact: Chandana Gurung Bhandari ([e-mail])

| Proprietary Name: | LCD Monitor |
|----------------------------|-------------------------------------------------------------------------------------------------------|
| Device Common Name: | Accessory to MRI system, Nuclear Magnetic Resonance Imaging<br>System, image processing, radiological |
| Classification Regulation: | 21 CFR 892.1000 |
| Class: | II |
| Panel: | Radiology |
| Product Code: | LNH |

#### Predicate device name: fMRI Hardware System

## Device Description

The LCD Monitor is designed for the purpose of viewing images for MRI applications within the MR environment. The high resolution panels combined with high performance image processing controller, provides the users extremely high definition and high quality medical image displays. The monitor comply with international EMC and safety standards for medical devices.

#### Intended Use

The LCD monitor is intended to be used by trained professionals as an fMRI viewing monitor within the MR environment.

This device must not be used for a life support system.

This device must not be used for diagnostics.

NordicNeuroLab AS - Traditional 510(k) LCD Monitor

Indications for Use Statement Page 4-2

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# Technological Characteristics and Substantial Equivalence

In all material respects, the LCD monitor is similar to the predicate device NordicNeuroLab fMRI hardware (K092253-LNH Subsystem - Visual system- in- room LCD Monitor). Testing was performed according to the internal company procedures and the monitor was safety certified to international standards.

Though some differences between the new devices and the predicate device exist, these differences do not raise new questions of safety and effectiveness.

## Compliance and Voluntary standard compliance

The subject device has been tested against and has passed the following standards:

- IEC 60601-1:2005, General Requirements for Electrical Safety .
- IEC 60601-1-2:2007, Electromagnetic Compatibility .

## Performance Testing

Prospectively defined verification and validation activities for the LCD Monitor assure that it meets all design and performance specifications as well as user needs when operated according to the operating instructions (Section 18).