Duns Number:354140220
Device Description: The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiati The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.
Catalog Number
-
Brand Name
OLINDA/EXM
Version/Model Number
2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 25, 2027
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
K163687
Product Code
IYX
Product Code Name
Camera, Scintillation (Gamma)
Public Device Record Key
0f2c186c-a8d2-41df-a68e-6a9269eb745d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 21, 2017
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |