FDA.reportPublic FDA data

Ultrasound System, Z.One PRO

Primary DI
00851315007013
Brand
Ultrasound System, Z.One PRO
Company
ZONARE MEDICAL SYSTEMS, INC.
Model
Z.One PRO
Device description
Diagnostic Ultrasound System
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00851315007013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851315007013008513150070138513150070130851315007013

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

Regulatory Flags#

DUNS number
096113340
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851315007037E9-4 Endocavity TransducerE9-42016-09-23
00851315007181E9-3 Endocavity TransducerE9-32016-09-23
00851315007006Ultrasound System, ZS3ZS32016-09-23
00851315007020L10-5 Linear Array TransducerL10-52016-09-23
00851315007044L8-3 Linear Array TransducerL8-32016-09-23
00851315007051L14-5sp Linear Array TransducerL14-5sp2016-09-23
00851315007068P4-1c Phased Array TransducerP4-1c2016-09-23
00851315007075C9-3 Curved Array TransducerC9-32016-09-23
00851315007082L14-5w Linear Array TransducerL14-5w2016-09-23
00851315007099C6-2 Curved Array TransducerC6-22016-09-23
00851315007105P8-3TEE Multiplane TransducerP8-3TEE2016-09-23
00851315007112A2CW Continuous Wave TransducerA2CW2016-09-23
00851315007129C8-3 3D Curved Array TransducerC8-3 3D2016-09-23
00851315007136C4-1 Curved Array TransducerC4-12016-09-23
00851315007143E9-3 3D Curved Array TransducerE9-3 3D2016-09-23
00851315007150C10-3 Curved Array TransducerC10-32016-09-23
00851315007167L20-5 Linear Array TransducerL20-52016-09-23
00851315007174C9-3sp Curved Array TransducerC9-3sp2016-09-23
00851315007198A5CW Continuous Wave TransducerA5CW2016-09-23
00851315007204Z-PAK Battery PackZ-PAK2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126311Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYN2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYN2025-12-05
00195278723963NAGE Healthcare Japan CorporationIYO2025-10-15
00195278723963NAGE Healthcare Japan CorporationIYN2025-10-15
00884838129276Ultrasound WorkspacePhilips Ultrasound LLCIYN2025-08-29
00195278875860VscanGE Vingmed Ultrasound A/SIYN2025-07-04
00195278875860VscanGE Vingmed Ultrasound A/SIYO2025-07-04
00195278910509VolusonGE Ultrasound Korea Ltd.IYN2025-06-04
00195278910509VolusonGE Ultrasound Korea Ltd.IYO2025-06-04
00884838125186Ultrasound WorkspacePhilips Ultrasound LLCIYN2025-03-24
00195278814685VolusonGE Healthcare Austria GmbH & Co OGIYO2025-01-08
00195278814685VolusonGE Healthcare Austria GmbH & Co OGIYN2025-01-08