FDA.reportPublic FDA data

Uroskop Omnia Max

Primary DI
04056869008981
Brand
Uroskop Omnia Max
Company
Siemens Healthcare GmbH
Model
10762473
Device description
Diagnostic Urology
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAASystem, x-ray, fluoroscopic, image-intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869008981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869008981040568690089814056869008981

GMDN Terms#

Term, Definition table
TermDefinition
Stationary uro-gynaecological fluoroscopic x-ray system, digitalA stationary diagnostic x-ray system with real-time fluoroscopic capabilities specifically designed for use in urological and/or gynaecological surgical and interventional procedures requiring real-time visualization of the pelvic area. It uses digital techniques for real-time image capture, display and manipulation and include spot-film capabilities as well as fluoroscopic features. It is commonly used for imaging and x-ray guided surgical or interventional procedures. The images can be viewed in both real-time and delayed formats and may include various levels of imaging processing and analysis 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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056869993973LUMINOS Q.namix R11574002115740022025-07-30
04056869993980LUMINOS Q.namix T11574003115740032025-07-30
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

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