FDA.reportPublic FDA data

Civco classic stepper sensor fixator

Primary DI
07290016936193
Brand
Civco classic stepper sensor fixator
Company
UC-CARE LTD
Model
FPRSA00022
Catalog number
FPRSA00022
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
07290016936193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016936193072900169361937290016936193

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
Serial number
true

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
07290016936117Roll Stand + Arm HRDGN00023HRDGN000232017-11-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
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75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08800133400003ZeTTA PACSTae Young Soft Co., Ltd.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.LLZ2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.LLZ2026-04-20
M722CD26103V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-04-20
M722CP26104V261040ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-04-20
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25
08800066200787JLK-CTPJLK, Inc.LLZ2026-03-25
08800066200794JLK-PWIJLK, Inc.LLZ2026-03-25
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.LLZ2026-02-24
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.LLZ2026-01-28