Duns Number:557804458
Device Description: ClearON Mobile provides easy touch based user interface to perform diagnosis of digital ra ClearON Mobile provides easy touch based user interface to perform diagnosis of digital radiograph images displayed on ClearOn Mobile. ClearON Mobile receives digital images from a flat panel detector and a X-ray generator. The software also manages patient data, stores and transfers diagnostic images in an internal database. It supports DICOM image file format which allows interoperability with other Radiography equipment in network environment.
Catalog Number
-
Brand Name
ClearON Mobile
Version/Model Number
ClearON Mobile
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
K183478
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
84c9cc6a-082b-4599-bb84-f101290cd07b
Public Version Date
March 18, 2019
Public Version Number
1
DI Record Publish Date
March 08, 2019
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 |