(115 days)
K092253-LNH
Not Found
No
The summary describes a standard LCD monitor for viewing fMRI images and mentions "high performance image processing controller" but does not mention AI, ML, or any related terms or concepts. The performance studies focus on verification and validation against design specifications, not on algorithmic performance metrics typical of AI/ML devices.
No
The device is described as a viewing monitor for fMRI images and explicitly states that it "must not be used for a life support system" and "must not be used for diagnostics," indicating it is for display purposes rather than directly treating or diagnosing a condition.
No
The "Intended Use / Indications for Use" section explicitly states, "This device must not be used for diagnostics."
No
The device description explicitly states it is an "LCD Monitor" and describes hardware components like "high resolution panels" and an "image processing controller," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This device must not be used for diagnostics."
- Function: The device is described as a "fMRI viewing monitor" for displaying images within the MR environment. Its primary function is to present images to trained professionals, not to perform diagnostic tests on biological samples (which is the core of IVD).
- Lack of IVD Characteristics: The description does not mention any interaction with biological samples, reagents, or the analysis of in vitro data.
Therefore, while it's a medical device used in a clinical setting, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LNH
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals as a fMRI viewing monitor within the MR environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K092253-LNH
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.
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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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: +47 55 70 70 95 Fax: +47 55 70 70 96
Primary Contact: Chandana Gurung Bhandari (chandana@nordicneurolab.com)
| Proprietary Name: | LCD Monitor |
|---|---|
| Device Common Name: | Accessory to MRI system, Nuclear Magnetic Resonance Imaging |
| 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).