Duns Number:635684694
Device Description: The Xmplar-dr is a full-body, low-dose X-ray scanner which produce digital X-ray images us The Xmplar-dr is a full-body, low-dose X-ray scanner which produce digital X-ray images used for diagnosis purpose in both trauma and general radiography cases, as well as forensic pathology cases.
Catalog Number
CL-08-0013-A11
Brand Name
LODOX
Version/Model Number
Xmplar-dr
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
K013999
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
c958ee03-dfe9-423c-ac90-6aabd1e5bb88
Public Version Date
November 12, 2020
Public Version Number
1
DI Record Publish Date
November 04, 2020
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. | 11 |