Duns Number:671280238
Device Description: Control Room Interface (CRI) is part of Visual System HD.CRI is the interface unit for vid Control Room Interface (CRI) is part of Visual System HD.CRI is the interface unit for video signal in (HDMI) and eye tracking video out (HDMI).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, Visual System HD.
Catalog Number
-
Brand Name
Control Room Interface
Version/Model Number
CRI-1.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K191032
Product Code
LNH
Product Code Name
System, Nuclear Magnetic Resonance Imaging
Public Device Record Key
b8c2c345-5d65-40ed-9e89-f6cf8163dc40
Public Version Date
June 02, 2020
Public Version Number
2
DI Record Publish Date
March 01, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |