FDA.reportPublic FDA data

UroNav

Primary DI
00884838107069
Brand
UroNav
Company
Philips DS North America LLC
Model
UroNav 4
Catalog number
784039
Device description
UroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician.
Published
2022-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
QTZRadiological Image Processing Software For Ablation Therapy Planning And Evaluation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
QTZRadiological Image Processing Software For Ablation Therapy Planning And EvaluationRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838107069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838107069008848381070698848381070690884838107069

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius55 Degrees Celsius
Special Storage Condition, Specify00Do not stack
Special Storage Condition, Specify00Fragile
Special Storage Condition, Specify00Keep away from rain
Special Storage Condition, Specify00This way up
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118983916
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838100114Invivo4535-302-233312020-04-17
00884838066991Invivo7840112016-09-23
00884838072558Invivo989603205282016-09-23
00884838072565Invivo989603203012016-09-23
00884838072572Invivo989603203022016-09-23
00884838073456Invivo989603208782016-09-23
00884838073463Invivo989603208792016-09-23
00884838081543Invivo7840122016-09-23
00884838082885Invivo989603210042017-07-28
00884838083592Invivo7840012016-09-23
00884838098459PhilipsdS FLEX-S 1.5T4598017299712021-06-11
00884838080997GE16ch Shoulder Coil4598008700112016-09-23
00884838081734InvivoBiopsy Grid (User-sterilized)4598015086412016-09-23
00884838107977MRI CoilsdS Microscopy 23mm, Ingenia 1.5T4598017950422021-10-28
00884838065390InvivoSENSE MSK M 8ch 1.5T4535303103522016-09-23
00884838072923KITS (Disposables)Needle Block, 8G9896032034532016-09-23
00884838072930KITS (Disposables)Needle Block, 12G9896032034632016-09-23
00884838072961KITS (Disposables)Needle Block, 18G9896032034832016-09-23
00884838072992KITS (Disposables)MRI Needle Sleeve 16G9896032043132016-09-23
00884838073067Invivo KITS (Disposables)Pillar Immobilization Plate BBC9896032035832016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M722CP26183V261830ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-07-17
00854393006084VelocityVARIAN MEDICAL SYSTEMS, INC.LLZ2026-07-16
G874AVARAVIEWER0010Avara ViewerAVARA SOFTWARE LLCLLZ2026-07-13
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977590TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26