Duns Number:180451106
Device Description: The SuniIQ Digital Radiography System is a semiconductor imaging device intended to acquir The SuniIQ Digital Radiography System is a semiconductor imaging device intended to acquire real time intra-oral dental radiography images in combination with a dedicated dental X-ray source and imaging software. The digital radiography system is available either with a #1 size sensor or a #2 size sensor. It is intended to be used by dentists to diagnose dental diseases.
Catalog Number
400-1321
Brand Name
SuniIQ
Version/Model Number
Sensor size #1
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
-
Product Code
MUH
Product Code Name
System,X-Ray,Extraoral Source,Digital
Public Device Record Key
8633c6f9-5993-4805-8318-fb5c57994286
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 17, 2017
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. | 6 |