FDA.reportPublic FDA data

SEDECAL

Primary DI
08436046002128
Brand
SEDECAL
Company
SEDECAL
Model
RAD SYSTEM NOVA FA
Device description
This Analog or Digital Radiographic System is 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.
Published
2016-10-31
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
CodeName
KPRSystem, X-Ray, Stationary
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090279000SEDECAL, MILLENNIUM PLUSSedecal., Sa.2009-03-11KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436046002128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436046002128084360460021288436046002128

GMDN Terms#

Term, Definition table
TermDefinition
Stationary basic diagnostic x-ray system, digitalAn assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Regulatory Flags#

DUNS number
510948979
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436046003651SEDECALODYSSEY24202025-03-21
08436046003668SEDECALODYSSEY24322025-03-21
08436046003675SEDECALODYSSEY24402025-03-21
08436046003682SEDECALODYSSEY24502025-03-21
08436046003699SEDECALODYSSEY+24202025-03-21
08436046003705SEDECALODYSSEY+24322025-03-21
08436046003712SEDECALODYSSEY+24402025-03-21
08436046003729SEDECALODYSSEY+24502025-03-21
08436046001404SEDECALHERCULES-322016-10-31
08436046001411SEDECALHERCULES-402016-10-31
08436046001428SEDECALHERCULES-502016-10-31
08436046001435SEDECALHERCULES-652016-10-31
08436046001442SEDECALHERCULES-802016-10-31
08436046001572SEDECALSM-20HF-B-D-T2016-10-28
08436046001589SEDECALSM-32HF-B-D-T2016-10-28
08436046001596SEDECALSM-40HF-B-D-T2016-10-28
08436046001602SEDECALSM-50HF-B-D-T2016-10-28
08436046002166SEDECALSM-40HF-B-D-VIR2016-10-31
08436046002173SEDECALMobileDiagnost wDR2016-10-31
08436046002296SEDECALProteus XR/f ST2017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800011150129DRGEMDRGEM CorporationMQB2026-05-20
08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
08800011150112DRGEMDRGEM CorporationMQB2025-08-26
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340277Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340284Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340697Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340727Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
08056600520051Nical Flat PanelNICAL SPAMQB2023-10-09
08436046003026SEDECALSEDECALKPR2021-02-15
08436046003033SEDECALSEDECALKPR2021-02-15
08436046002388SEDECALSEDECALMQB2020-11-20
08436046002517SEDECALSEDECALMQB2020-05-29
08436046002456SEDECALSEDECALMQB2019-11-30
08800011121235FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121242FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121259FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121266FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121273FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121280FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121297FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121303FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121310FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121327FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121334FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121341FDR ClinicaDRGEM CorporationKPR2019-11-20