Inroom Viewing Device
Basic Information
- Brand Name
- Inroom Viewing Device
- Primary DI
- 07090042051033
- Version / Model
- LDC 3.0
- Company Name
- Nordicneurolab AS
- Labeler DUNS
- 671280238
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2020-06-02
- Public Version Status
- Update
- Public Device Record Key
- b1e483db-9cca-4912-b2c8-5a0a42a54ecf
Device Description
NordicNeuroLab’s LCD monitor (NNL MRI InroomViewingDevice LCD 40) is a complete, state-of-the-art solution designed specifically for use in the MR environment. LCD 40 is part of NordicNeuroLab’s VisualSystem. The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays or by an in-room LCD monitor. LCD 40 is a 40 inch LCD (Liquid Crystal Display) monitor, compatible with MR system up to 3T. The LCD monitor uses standard DVI display signal, and can be connected to any computer or video output device with digital outputs. The LCD monitor are capable to show video signals in 4K UHD format (3840x2160 pixels) The LCD monitor is equipped with a integrated VGA camera.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35373 | Visual stimulator | An electronic device used to apply visual stimuli (e.g., shifting patterns of light) to a patient's eyes. This device typically presents light to the eye through an optical system (optical stimulator), or light is viewed directly from an illuminated screen (direct-view stimulator), or light-emitting diode (LED) stimulating goggles. It is typically used as a component of several other devices such as refractors, scanning ophthalmoscopes, visual evoked potential (VEP) recording systems, or an electroretinograph (ERG). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07090042051033 | GS1 |
Customer Contacts
- Phone
- +4755707095
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092253 | 000 |