Duns Number:801390100
Device Description: ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports Immersive ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options.
Catalog Number
-
Brand Name
ImmersiveTouch
Version/Model Number
ImmersiveTouch4
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
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
K140860
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
3bd3ff3c-1303-403c-b0f0-bdb785be078a
Public Version Date
August 20, 2020
Public Version Number
2
DI Record Publish Date
August 07, 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. | 2 |