FDA.reportPublic FDA data

Ysio Max

Primary DI
04056869004273
Brand
Ysio Max
Company
Siemens Healthcare GmbH
Model
10762470
Device description
Radiography System
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPRSystem, x-ray, stationary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869004273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869004273040568690042734056869004273

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.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04068151020076syngo Dynamics117081242026-03-19
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
04068151047950MAGNETOM Flow.Elite118783452026-01-19
04056869299297MAMMOVISTA B.smartVB72026-01-16
04068151000887AI-Rad Companion Prostate MR116660382026-01-15
04056869981888syngo.MR Applications115831692025-11-25
04056869290355syngo.CT CaScoring115464022025-11-24
04068151022162Syngo Carbon Clinicals118240112025-11-24
04056869297309MOBILETT Impact116475002025-11-20
04056869959009syngo.via RT Image Suite116646182025-11-18
04068151011388syngo.via RT Image Suite116646182025-11-18
04056869962214YSIO X.pree115740012025-08-11
04056869993973LUMINOS Q.namix R115740022025-07-30
04056869993980LUMINOS Q.namix T115740032025-07-30
04068151010404AI-Rad Companion Organs RT118238752025-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971576833702uDRShanghai United Imaging Healthcare Co., Ltd.KPR2026-03-08
06971576833719uDRShanghai United Imaging Healthcare Co., Ltd.KPR2026-03-08
00858340006523Del Medical, Inc.Del Medical, Inc.KPR2026-03-05
00858340006530Del Medical, Inc.Del Medical, Inc.KPR2026-03-05
08800098700040XVISION-525GEMSS Healthcare Co., Ltd.KPR2026-01-16
00817100020278KDR Floor Mount+ SystemKONICA MINOLTA MEDICAL IMAGING U.S.A., INC.KPR2026-01-08
00817100021282KDR Floor Mount SystemKONICA MINOLTA MEDICAL IMAGING U.S.A., INC.KPR2026-01-08
00195278913814DefiniumGE Hualun Medical Systems Co., LtdKPR2025-09-05
04056869962214YSIO X.preeSiemens Healthcare GmbHKPR2025-08-11
00817100021268KDR DDR Primary U Arm KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.KPR2025-07-30
03663999000405EOSedgeEOS IMAGINGKPR2025-05-14
B619X20Q9XPERT20KubtecKPR2025-03-26
08800018421505EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018421604EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018421703EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018421802EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018421901EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018422007EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018422106EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018422205EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018422304EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018422403EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018425503EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018425602EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018425701EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018425800EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018425909EXSYS DEXiDRTECH CorporationKPR2025-03-25
00860001404753MasteRadMedicatech Usa, Inc.KPR2024-12-20
08806095799636NASamsung Electronics Co., Ltd.KPR2024-10-18
08806095799643NASamsung Electronics Co., Ltd.KPR2024-10-18