Home GUDID M430S80200051
ACTEON
Primary DI M430S80200051
Brand ACTEON
Company SOPRO
Model CAPT SOPIX² T2 USB2 CONDO
Catalog number S_802_0005
Device description """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."""
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name MUH System,X-Ray,Extraoral Source,Digital
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MUH System, X-Ray, Extraoral Source, Digital Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M430S80200051 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental digital imaging sensor, intraoral An analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.
Regulatory Flags# DUNS number 264205501 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 03760278260434 ACTEON SYSTEME PSPIX WIN MAC (Only) 997090 2018-11-19 03760278260939 ACTEON SYSTEME PSPIX WIN MAC S_702_0011 2018-11-19 M430S70200111 ACTEON SYSTEME PSPIX WIN MAC S_702_0011 2016-09-24 03760278267587 ACTEON C50 - INTRAORAL CAMERA S_C50_0008 2024-05-02 03760278267594 ACTEON C50 - INTRAORAL CAMERA D S_C50_0009 2024-05-02 03760278267020 ACTEON C50 - INTRAORAL CAMERA D S_C50_0002 2022-09-01 03760278267037 ACTEON C50 - INTRAORAL CAMERA D S_C50_0002 2022-09-01 03760278260045 COMEG MEDICAL TECHNOLOGIES UBIPACK ENT SYSTEM SK101016 2017-12-19 03760278260427 COMEG MEDICAL SOURCE LED SOPRO 281 BLANC (Only) 998360 2018-11-19 M430S21800061 COMEG MEDICAL SOPRO 218 - SOURCE DE LUMIERE XENON 180W - SOPRO S_218_0006 2016-09-24 M430S21800091 COMEG MEDICAL S218 SOPRO US OLYMPUS S_218_0009 2016-09-24 M430S21800111 COMEG MEDICAL S218 SOPRO US OLYMPUS S_218_0011 2016-09-24 M430S21800121 COMEG MEDICAL S218 SOPRO US WOLF S_218_0012 2016-09-24 M430S23000051 COMEG MEDICAL SOPRO 230 - SOURCE DE LUMIERE XENON 300W - SOPRO S_230_0005 2016-09-24 M430S23000091 COMEG MEDICAL S230 SOPRO US OLYMPUS S_230_0009 2016-09-24 M430S23000111 COMEG MEDICAL S230 SOPRO US WOLF S_230_0011 2016-09-24 M430S28100011 COMEG MEDICAL SOURCE LED SOPRO 281 ORL S_281_0001 2016-09-24 M430S28100021 COMEG MEDICAL SOURCE LED SOPRO 281 BLANC S_281_0002 2016-09-24 M430S29800021 COMEG MEDICAL SOURCE LED SOPRO S298 S_298_0002 2016-09-24 03760278260342 COMEG MEDICAL TECHNOLOGIES PENTAX Medical LED Light Source S_281P_0104 2019-07-16
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