Duns Number:557804458
Device Description: Xmaru PACS is a software program designed to provide image acquisition, processing and ope Xmaru PACS is a software program designed to provide image acquisition, processing and operational management functions for Digital Radiography.
Catalog Number
-
Brand Name
Xmaru PACS
Version/Model Number
Xmaru PACS
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
K160579
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
d76ad316-7ace-4ccc-a5f0-eb75fdeb283a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 11, 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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 110 |