FDA.reportPublic FDA data

ARCADIS Avantic

Primary DI
04056869009001
Brand
ARCADIS Avantic
Company
Siemens Healthcare GmbH
Model
10143408
Device description
mobile C-arm
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OXOImage-intensified fluoroscopic x-ray system, mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXOImage-Intensified Fluoroscopic X-Ray System, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051133000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051133000ARCADIS AVANTICSiemens Medical Solutions USA, Inc.2005-06-01OXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869009001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869009001040568690090014056869009001

GMDN Terms#

Term, Definition table
TermDefinition
Portable general-purpose fluoroscopic x-ray system, analogueAn assembly of devices that comprise a portable (moved from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time analogue or analogue-to-digital techniques for image capture, display and manipulation used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested/injected x-ray contrast medium.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)888-7436XX@XX.XX
+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
313217003
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056869987187MAMMOMAT B.brilliant11372950113729502024-04-20
04056869009179Multitom Rax10860700108607002016-09-24
04068151011807ARTIS icono.explore floor118320002026-05-15
04068151018226syngo Application Software118312342026-05-15
04068151033779ARTIS genio floor118321002026-05-15
04056869991771myAblation Guide108313732026-05-11
04056869295923ARTIS icono ceiling113281002022-10-01
04056869263168NAEOTOM Alpha113300032021-10-13
04056869063317ARTIS icono biplane113276002020-01-10
04056869149325ARTIS icono floor113277002020-01-10
04056869046877ARTIS pheno108490002017-05-15
04068151033977AI-Rad companion Brain MR118304812026-04-14
04068151020076syngo Dynamics117081242026-03-19
04056869973371AI-Rad Companion Organs RT116655082025-04-30
04068151036749MAGNETOM Flow.Rise117884172026-01-20
04056869299556MAGNETOM Flow.Neo115698352026-01-19
04056869299594MAGNETOM Flow.Neo115698392026-01-19
04068151034196MAGNETOM Flow.Elite118519112026-01-19
04068151036732MAGNETOM Flow.Elite118519122026-01-19
04068151047943MAGNETOM Flow.Neo118783442026-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.OXO2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.OXO2026-04-30
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.OXO2026-03-25
00850079606050EmitterOXOS Medical, Inc.OXO2026-03-25
00198953052488AlliaGE MEDICAL SYSTEMSOXO2025-12-17
08809244060700GenorayGENORAY CO., LTD.OXO2025-12-01
00613994462428O-ArmMEDTRONIC NAVIGATION, INC.OXO2025-11-27
B225100000200Orthoscan Versa Mini C-ArmZiehm-Orthoscan, Inc.OXO2025-07-11
08055186671096FUJIFILM Healthcare Americas CorporationA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2025-07-02
08800018422601EXTRON 3DRTECH CorporationOXO2025-06-17
08809244060090GenorayGENORAY CO., LTD.OXO2025-05-02
00195278685001OECGE Hualun Medical Systems Co., LtdOXO2025-01-09
00860001123418CassetteOXOS Medical, Inc.OXO2025-01-01
00860001123425EmitterOXOS Medical, Inc.OXO2025-01-01
00860008892706Foot PedalOXOS Medical, Inc.OXO2025-01-01
00860008892713Wired ChargerOXOS Medical, Inc.OXO2025-01-01
00860008892737CartOXOS Medical, Inc.OXO2025-01-01
00860008892744MC2 AppOXOS Medical, Inc.OXO2025-01-01
00860008892782MC2 Portable X-ray SystemOXOS Medical, Inc.OXO2025-01-01
08053307591070TRIDENTTECHNIX SPAOXO2024-11-06
08053307591087TRIDENTTECHNIX SPAOXO2024-11-06
00643169618121O-armMEDTRONIC NAVIGATION, INC.OXO2024-10-10
00763000709631O-armTM O2 Imaging SystemMEDTRONIC NAVIGATION, INC.OXO2024-08-26
00193982184506EXCELSIUS3DGLOBUS MEDICAL, INC.OXO2024-06-26
00193982184537EXCELSIUS3DGLOBUS MEDICAL, INC.OXO2024-06-26
00884838112292Zenition 90Philips Medical Systems Nederland B.V.OXO2024-05-28