Duns Number:204112346
Device Description: The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool i The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor.
Catalog Number
ASY-2000
Brand Name
THiA
Version/Model Number
PMI001OCT21
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K203578,K203578
Product Code
NQQ
Product Code Name
System, Imaging, Optical Coherence Tomography (Oct)
Public Device Record Key
37731bb2-5f6f-472f-bc63-0fa17767eb91
Public Version Date
September 07, 2021
Public Version Number
1
DI Record Publish Date
August 30, 2021
Package DI Number
10754016215015
Quantity per Package
1
Contains DI Package
00754016215018
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Single unit package