FDA.reportPublic FDA data

SEDECAL

Primary DI
08436046003286
Brand
SEDECAL
Company
SEDECAL
Model
SM-IV
Catalog number
CB40
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
2023-09-19
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232185000SM-IVSedecal., Sa.2023-08-21IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436046003286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436046003286084360460032868436046003286

GMDN Terms#

Term, Definition table
TermDefinition
Mobile basic diagnostic x-ray system, analogueAn assembly of devices that comprise an analogue general-purpose mobile diagnostic x-ray system used in a variety of routine x-ray imaging applications. It is typically an x-ray film based system using analogue or analogue-to-digital techniques for image capture and display. The mobile design allows it to operate on-line or by battery and to be driven or pushed by an operator to various locations within a building. 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
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 CorporationIZL2026-05-20
08800011150136DRGEMDRGEM CorporationIZL2026-05-20
07350011170005TrueMobileSolutions For Tomorrow ABIZL2026-05-18
08800184900002X-RAYNEUF Inc.IZL2026-05-11
08800184900019X-RAYNEUF Inc.IZL2026-05-11
08908021109097PRORAD ATLAS ULTRAPORTABLEPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-05-07
08908021109103PRORAD ATLAS ULTRAPORTABLE PLUSPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-04-16
08800040900108Diagnostic X-ray UnitPoskom Co., Ltd.IZL2026-04-15
08800040900221Airbile-100Poskom Co., Ltd.IZL2026-04-15
08800040900245AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900252AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900269AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900276AirRay-miniPoskom Co., Ltd.IZL2026-04-15
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.IZL2026-03-25
00850079606050EmitterOXOS Medical, Inc.IZL2026-03-25
04547410571134FDR AQROFUJIFILM CORPORATIONIZL2026-03-20
00858340006479Del Medical, Inc.Del Medical, Inc.IZL2026-03-05
08800060100229REMEX Xcam6REMEDI CO.,LTD.IZL2026-01-22
04056869297309MOBILETT ImpactSiemens Healthcare GmbHIZL2025-11-20
08800011150105DRGEMDRGEM CorporationIZL2025-08-26
08800011150112DRGEMDRGEM CorporationIZL2025-08-26
08800070400074HnX-P1H&abyz Co., LtdIZL2025-08-12
08800070400166HnX-PBH&abyz Co., LtdIZL2025-08-12
08436046003651SEDECALSEDECALIZL2025-03-21
08436046003668SEDECALSEDECALIZL2025-03-21
08436046003675SEDECALSEDECALIZL2025-03-21
08436046003682SEDECALSEDECALIZL2025-03-21
08436046003699SEDECALSEDECALIZL2025-03-21
08436046003705SEDECALSEDECALIZL2025-03-21
08436046003712SEDECALSEDECALIZL2025-03-21