Duns Number:068780729
Device Description: Weight Bearing CT Imaging for Foot, Ankle, and Knee. Non-Load Bearing imaging of upper ext Weight Bearing CT Imaging for Foot, Ankle, and Knee. Non-Load Bearing imaging of upper extremities.
Catalog Number
-
Brand Name
LineUP
Version/Model Number
1030-115
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
K180727
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
95ecc0e0-dd7e-4e74-bbd1-f00e40fcda2a
Public Version Date
October 11, 2018
Public Version Number
1
DI Record Publish Date
September 10, 2018
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. | 10 |