FDA.reportPublic FDA data

C9150LA

Primary DI
00860007188305
Brand
C9150LA
Company
Fujifilm Healthcare Americas Corporation
Model
C9150LA
Device description
4-way Laparoscopic Ultrasound Transducer/Smart Connector
Published
2021-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K134016000
K163505000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K134016000ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNERHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014-03-28IYN
K163505000ARIETTA PRECISIONHitachi , Ltd.2017-05-30IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869047000448PreviousGS10
00860007188305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869047000448008690470004488690470004480869047000448
00860007188305008600071883058600071883050860007188305

GMDN Terms#

Term, Definition table
TermDefinition
Surgical ultrasound imaging transducerA hand-held ultrasound imaging transducer assembly designed to be positioned within a surgical site for localized intraoperative imaging applications. It is sometimes referred to as a surgical probe or fingertip probe. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. This group of devices includes ultrasound imaging transducer assemblies used with A-mode, B-mode, M-mode, Doppler, colour Doppler (CD), and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Regulatory Flags#

DUNS number
603156043
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854904006008Synapse Radiology PACSSynapse Radiology PACS Software License2016-09-23
00869047000431Synapse Select4.X.X2018-09-27
00854904006015Synapse CardioVascularSynapse Cardiology PACS Software License2016-09-23
00860014745003FUJIFILM Stiffening Wire (SW-2000)SW-20002025-12-18
00854904006039Synapse PathologySynapse Pathology Software License2023-06-16
00860007188343Transducer S12BP4S12BP42022-06-08
00854904006060Synapse Enterprise ViewerSynapse Enterprise Viewer2019-05-23
00854904006022Synapse MPR FusionSynapse MPR Fusion Software License2016-09-23
00854904006053Synapse MobilitySynapse Mobility Base Package2016-09-29
00860007188312UST 5550-RUST 5550-R2021-07-01
00860007188329UST-9150UST-91502021-07-01
00860007188336UST-52114P-BUST-52114P-B2021-07-01
00869047000455D&K TechnologiesDK-ARM-KIT2021-02-15
00869047000462D&K TechnologiesDK-STAND-KIT2021-02-15
00869047000448HITACHI HEALTHCARE AMERICASC9150LA2020-06-29
00869047000400HITACHI HEALTHCARE AMERICASUST-5550-R2018-07-23
00869047000417HITACHI HEALTHCARE AMERICASUST-91502018-07-23
00869047000424HITACHI HEALTHCARE AMERICASUST-52114P-B2018-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27