Duns Number:043835081
Device Description: A device that scans photostimulable phosphor plates that have been exposed in the place of A device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.This kit contains an installation disc, USB cable and power supply, PSPs, barrier envelopes, barrier film rolls, PSP wipes, and a scanner cleaning sheet.
Catalog Number
-
Brand Name
ScanX Swift Digital Imaging System
Version/Model Number
G8010
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K013893,K013893,K013893
Product Code
MUH
Product Code Name
System,X-Ray,Extraoral Source,Digital
Public Device Record Key
7d5ff76f-f9db-45c2-9270-810f42142eba
Public Version Date
August 23, 2018
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
D678G80001
Quantity per Package
1
Contains DI Package
D678G80100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |