Duns Number:101533727
Device Description: V3.0.2 Operating Software for Codonics Horizon® Imagers serial number prefix 53C, 54C, and V3.0.2 Operating Software for Codonics Horizon® Imagers serial number prefix 53C, 54C, and 55C
Catalog Number
-
Brand Name
Codonics Horizon® Operating Software
Version/Model Number
3.0.2
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
K021054
Product Code
LMC
Product Code Name
Camera, Multi Format, Radiological
Public Device Record Key
df10733d-9b4a-4e49-b8ab-5d65644681ee
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
August 23, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |