FDA.reportPublic FDA data

SEDECAL

Primary DI
08436046003668
Brand
SEDECAL
Company
SEDECAL
Model
ODYSSEY
Catalog number
2432
Device description
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
2025-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IZLSystem, X-Ray, Mobile
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192011000PhoeniXSedecal., Sa.2019-09-25IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436046003668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436046003668084360460036688436046003668

GMDN Terms#

Term, Definition table
TermDefinition
Mobile basic diagnostic x-ray system, digitalAn assembly of devices that comprise a digital general-purpose mobile 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 and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging and for interventional and intraoperative imaging. It consists of basic modular configurations that can be upgraded. 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 Pressure700 millibar1060 millibar
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

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
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
08436046002302SEDECALProteus XR/f ET2017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08800011150129DRGEMDRGEM CorporationMQB2026-05-20
08800011150129DRGEMDRGEM CorporationIZL2026-05-20
08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08800011150136DRGEMDRGEM CorporationIZL2026-05-20
08809413811096ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811126ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811133ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08800184900002X-RAYNEUF Inc.IZL2026-05-11