Duns Number:144124518
Device Description: TIMS Streamer transmits any live medical modality video over networks - LAN, WAN, VPN, and TIMS Streamer transmits any live medical modality video over networks - LAN, WAN, VPN, and Internet. Provides secure, encrypted and HIPPA Compliant information. Usage includes live training, mentoring, proctoring and monitoring. Functionality includes recording segments and entire procedures.
Catalog Number
072000-100
Brand Name
TIMS System
Version/Model Number
TIMS Streamer 1B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K001947
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
59e288de-a0df-4e14-b555-b88c2b2b5c4c
Public Version Date
April 22, 2019
Public Version Number
1
DI Record Publish Date
April 12, 2019
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. | 58 |