ACTEON - "The SOPIX series digital X-ray imaging systems - SOPRO

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."

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More Product Details

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

Product Characteristics

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 Details

Product Code

MUH

Product Code Name

System,X-Ray,Extraoral Source,Digital

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOPRO" Characteristics
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