SEDECAL 10451-03

GUDID 08436046002548

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

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Primary Device ID08436046002548
NIH Device Record Key30c06542-2684-4516-91b5-8b006674bb29
Commercial Distribution StatusIn Commercial Distribution
Brand NameSEDECAL
Version Model NumberSoltus 450
Catalog Number10451-03
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

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 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
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 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
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 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
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 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
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 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
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 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
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 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
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 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
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 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
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 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
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 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
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 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
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 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
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 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108436046002548 [Primary]
GS108436046002548 [Primary]
GS108436046002548 [Primary]
GS108436046002548 [Primary]
GS108436046002548 [Primary]
GS108436046002548 [Primary]
GS108436046002548 [Primary]
GS108436046002548 [Primary]
GS108436046002548 [Primary]
GS108436046002548 [Primary]
GS108436046002548 [Primary]
GS108436046002548 [Primary]
GS108436046002548 [Primary]
GS108436046002548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
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 Date2020-07-31
Device Publish Date2020-07-23

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

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