Duns Number:433051802
Device Description: Acteon Imaging Suite software program is an application software for general dental and ma Acteon Imaging Suite software program is an application software for general dental and maxillofacial diagnostic imaging. Itcontrols exam retrieval, display, enhancement, and saving of digital images from various digital imagingsystems. It stores and communicates these images within the system or across computer systems atdistributed locations.
Catalog Number
W0900046
Brand Name
Acteon Imaging Suite
Version/Model Number
ACTEON IMAGING SUITE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K192165
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
5fe3fa1c-d276-4e44-b340-e8331e0be07b
Public Version Date
April 16, 2020
Public Version Number
1
DI Record Publish Date
April 08, 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. | 63 |