Duns Number:144124518
Device Description: TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functional TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
Catalog Number
061000-FEES-L
Brand Name
TIMS System
Version/Model Number
TIMS 2000 FEES-L 42M
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
bc88d4ea-eefb-4dbb-a474-a3bf91bc0149
Public Version Date
August 01, 2022
Public Version Number
1
DI Record Publish Date
July 22, 2022
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 |