FDA.reportPublic FDA data

Ultrasonix Medical Corporation

Primary DI
08294361800023
Brand
Ultrasonix Medical Corporation
Company
ANALOGIC CORPORATION
Model
18.000.000-02
Device description
SonixTOUCH Q+ Ultrasound System
Published
2017-11-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08294361800023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08294361800023082943618000238294361800023

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-604-279-8550techsupport@bkultrasound.com

Regulatory Flags#

DUNS number
019677418
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
90814277020035Pathfinder Shadow BK-T10-77322S-012016-09-17
90814277020042Pathfinder Shadow 10-77247S-012016-09-17
90814277020059Pathfinder Shadow (Aloka)10-77246S-012016-09-17
90814277020066Pathfinder Small Multi-Tool Instrument Clamp10-77260S-012016-09-17
90814277020073Pathfinder Large Multi-Tool Instrument Clamp10-77249S-012016-09-17
90814277020080Pathfinder Beacon10-77248S-012016-09-17
90814277020097Pathfinder Tracer10-77243S-012016-09-17
90814277020103Pathfinder Long Probe10-77242S-012016-09-17
90814277020110Pathfinder Tracked Probe10-77241S-012016-09-17
08294360350536Ultrasonix Medical Corporation00.035.0532017-11-17
08294360246341Ultrasonix Medical Corporation00.024.6342017-11-17
08294360350352Ultrasonix Medical Corporation00.035.0352017-11-17
08294360350499Ultrasonix Medical Corporation00.035.0492017-11-17
08294360350567Ultrasonix Medical Corporation00.035.0562017-11-17
08294360350581Ultrasonix Medical Corporation00.035.0582017-11-17
08294360350604Ultrasonix Medical Corporation00.035.0602017-11-17
08294360350611Ultrasonix Medical Corporation00.035.0612017-11-17
08294360350635Ultrasonix Medical Corporation00.035.0632017-11-17
08294360350642Ultrasonix Medical Corporation00.035.0642017-11-17
08294360350666Ultrasonix Medical Corporation00.035.0662017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
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00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYO2026-07-24
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00841436122672Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125338Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125819Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126281Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126304Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00840432200216BladderScan®VERATHON INCIYO2026-07-22
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
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