Duns Number:635684694
Device Description: The Xmplar-dr is a full body, low dose, x-ray scanner which produce digital x-ray images u The Xmplar-dr is a full body, low dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiology cases, as well as forensic pathology cases.
Catalog Number
CL-08-0012
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
2d021590-0f5a-4fc5-ba0a-06ac27a3ee29
Public Version Date
August 20, 2021
Public Version Number
1
DI Record Publish Date
August 12, 2021
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 |