Duns Number:781155176
Device Description: The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide au The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
Catalog Number
-
Brand Name
Communication Control
Version/Model Number
22
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133670
Product Code
LNH
Product Code Name
System, Nuclear Magnetic Resonance Imaging
Public Device Record Key
939edac5-8360-4c52-87e5-616000f47610
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 16, 2017
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. | 75 |