SEDECAL

GUDID 08436046003033

The Proteus XR/f ET Radiographic Systems with (or without) Digital Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

SEDECAL

Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital
Primary Device ID08436046003033
NIH Device Record Key2312c305-89ea-4d85-95a0-367b55614056
Commercial Distribution StatusIn Commercial Distribution
Brand NameSEDECAL
Version Model NumberProteus XR/f ET
Company DUNS510948979
Company NameSEDECAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS108436046003033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-23
Device Publish Date2021-02-15

On-Brand Devices [SEDECAL]

08436046002364Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002494Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002487Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002470Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002463Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002456Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002449Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002432Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002609This mobile digital radiographic system is intended for use by a qualified/trained doctor or tec
08436046002593This mobile digital radiographic system is intended for use by a qualified/trained doctor or tec
08436046002586This mobile digital radiographic system is intended for use by a qualified/trained doctor or tec
08436046002579This mobile digital radiographic system is intended for use by a qualified/trained doctor or tec
08436046002517The SEDECAL X PLUS LP PLUS Radiographic Systems with (or without) Digital Detector are intended
08436046002500The SEDECAL X URS Radiographic System is intended for use by a qualified/trained doctor or techn
08436046002562Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002555Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002548Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002531Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002388The CHALLENGEX AP Radiographic System is intended for use by a qualified/trained doctor or tech
08436046003033The Proteus XR/f ET Radiographic Systems with (or without) Digital Detector are intended for use
08436046003026The Proteus XR/f ST Radiographic Systems with (or without) Digital Detector are intended for use
08436046002937Stationary diagnostic x-ray table
08436046002241Floor mounted radiological tube stand
08436046001954Ceiling Mount X-ray tube stand
08436046001947Ceiling Mount X-ray tube stand
08436046001930Ceiling Mount X-ray tube stand
08436046000995Floor mounted diagnostic x-ray tube stand
08436046000988Floor mounted diagnostic x-ray tube stand
08436046003019Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046003002Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002999Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002982Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002975Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002968Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002951Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002944Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046001879This is a portable digital diagnostic x-ray system Intended for use by a qualified/trained docto
08436046003170Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046003163Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046003156Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046003149Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046003132Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046003125Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046003118Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046003101Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046003293Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046003286Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046003279Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046003262Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046003095Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject

Trademark Results [SEDECAL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SEDECAL
SEDECAL
74630773 not registered Dead/Abandoned
SEDECAL, S.A.
1995-02-06

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