FDA.reportPublic FDA data

UST-9150

Primary DI
00860007188329
Brand
UST-9150
Company
Fujifilm Healthcare Americas Corporation
Model
UST-9150
Device description
Ultrasound Laparoscopic Probe
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
K122537000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122537000PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2013-04-12IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869047000417PreviousGS10
00860007188329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869047000417008690470004178690470004170869047000417
00860007188329008600071883298600071883290860007188329

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
00860007188305C9150LAC9150LA2021-07-01
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
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

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Primary DI, Brand, Company table
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00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYN2026-06-24
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