Duns Number:264205501
Device Description: "The SOPIX series digital X-ray imaging systems are intended to be used by a dental practi "The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient’smouth just like a silver fi lm) captures the X-rays produced by the generator. Then it transmits this data to the computer to displaythe X-ray image on the screen.All the images captured with the SOPIX series system can be recalled onto the screen with the Sopro Imaging software provided withthe system. This software manages the display, processing and storage of images taken with the SOPIX series system.A.C.E™ (Automatic Control Exposure) technology, patented by SOPRO, provides the system with outstanding features. In real timeit analyses the quantity of energy received by the sensor, which fi xes the image acquisition once it has received the energy neededto produce a good-quality image. As a result, every image is protected against overexposure."
Catalog Number
S_802_0005
Brand Name
ACTEON
Version/Model Number
CAPT SOPIX² T2 USB2 CONDO
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
K092329
Product Code
MUH
Product Code Name
System,X-Ray,Extraoral Source,Digital
Public Device Record Key
cbb1f28a-2b1f-4c27-bc84-a8b1ce3319c7
Public Version Date
July 06, 2018
Public Version Number
3
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 |