Duns Number:264205501
Device Description: "The PSPIX system is a laser X-ray device designed to digitize, display and erase intra or "The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oralx-ray images stored in imaging plates (IPs) - also known as phosphor plates."
Catalog Number
S_702_0011
Brand Name
ACTEON
Version/Model Number
SYSTEME PSPIX WIN MAC
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
K151053
Product Code
MUH
Product Code Name
System,X-Ray,Extraoral Source,Digital
Public Device Record Key
a04adfb8-cd61-43fa-b146-7b1a6eee3e82
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
September 24, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |