FDA.reportPublic FDA data

Roll Stand + Arm

Primary DI
07290016936117
Brand
Roll Stand + Arm
Company
UC-CARE LTD
Model
HRDGN00023
Catalog number
HRDGN00023
Published
2017-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100784000UC-CARE NAVIGO SYTEMUC-CARE , Ltd.2011-11-01LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016936117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016936117072900169361177290016936117

GMDN Terms#

Term, Definition table
TermDefinition
Rectal ultrasound navigational image processorA mobile, mains electricity (AC-powered) device intended to be used in conjunction with an ultrasound imaging system and rectal ultrasound transducer to display two- and three-dimensional (3-D) ultrasound images of tissues (e.g., the prostate). It consists of a personal computer (PC) based workstation which processes data from the ultrasound imaging system, and a mechanical assembly intended to mount and track the rectal ultrasound transducer to generate a real-time 3-D image. Depending on specific software, packages may also allow for biopsy navigation and further image processing/data management.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
649551124
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016936278SmartBxFPRMC00037FPRMC000372026-03-29
07290016936322Box of 80 SmartBx Disposable CassettesFPRPR00011FPRPR000112026-03-29
07290016936339Box of 10 SmartBx Disposable Needle CribsFPRPR00012FPRPR000122026-03-29
07290016936360SmartBx Spare partsFPRMC00031FPRMC000312026-03-29
07290016936001Navigo™ Workstation FPRMC0016AFPRMC0016A2017-11-15
07290016936018Computer (Industrial)FPRCO00011FPRCO000112017-11-15
07290016936025Probe sensor assembly for BK 8808 (square)FPRSA00006FPRSA000062017-11-15
07290016936032Probe sensor assembly for BK 8818 and 8808e (square)FPRSA00007FPRSA000072017-11-15
07290016936049Probe sensor assembly for Hitachi V53W (square)FPRSA00008FPRSA000082017-11-15
07290016936056Probe sensor assembly for GE E8CS (square)FPRSA00009FPRSA000092017-11-15
07290016936063Probe sensor assembly for BK 8667 (square)FPRSA00011FPRSA000112017-11-15
07290016936070Probe sensor assembly for MindRayFPRSA00013FPRSA000132017-11-15
07290016936087Probe sensor assembly for GE E8CS FPRSA00014FPRSA000142017-11-15
07290016936094Probe sensor assembly for Hitachi V53W FPRSA00012FPRSA000122017-11-15
07290016936100Ascension transmitter Cubic AssemblyASMCH00034ASMCH000342017-11-15
07290016936124Probe sensor assembly for EndoCareFPRSA00015FPRSA000152017-11-15
07290016936131Probe sensor assembly for D&K 8848FPRSA00016FPRSA000162017-11-15
07290016936148Probe sensor assembly for Civco 8848FPRSA00017FPRSA000172017-11-15
07290016936155Probe sensor assembly for Hitachi EUP-U533FPRSA00018FPRSA000182017-11-15
07290016936162Probe sensor assembly for GE BE9CSFPRSA00019FPRSA000192017-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953050996SnapShot FreezeGE Medical Systems, L.L.C.LLZ2026-10-19
05745000308385Cercare Medical NeurosuiteCercare Medical A/SLLZ2026-10-17
05745000308392Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-10-17
05745000308408Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-10-17
05745000308361Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual ExCercare Medical A/SLLZ2026-10-16
75401622502301Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-16
00889024713390ROSA® ShoulderOrthosoft IncLLZ2026-10-15
B037FFSMD0Synapse MobilityResolutionMD Inc.LLZ2026-10-15
B037NLIVD0Nicolab Image ViewerResolutionMD Inc.LLZ2026-10-15
B037RESMDD0ResolutionMDResolutionMD Inc.LLZ2026-10-15
00860013868918MICSI-PETMicroStructure Imaging, Inc.LLZ2026-10-14
00745426000059MiPACS V5Medicor ImagingLLZ2026-10-12
75401622522132Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-08
00198953200421EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
17540262200126Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-10-05
00884838120433SmartCTPhilips Medical Systems Nederland B.V.LLZ2026-09-28
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
05745000308323Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-01-30
05745000308330Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-01-30
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00195278951700EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
00195278951717EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08