FDA.reportPublic FDA data

I-Streme Echo Ultrasound Software

Primary DI
00850921007202
Brand
I-Streme Echo Ultrasound Software
Company
INTERSON CORP
Model
x.x
Published
2017-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850921007202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850921007202008509210072028509210072020850921007202

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
079884004
Device count
1
Premarket exempt
true
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850921007257VPS Rhythm DLX Ultrasound ProbeSP-DLX200DLX-200-USP2020-10-30
00850921007271VPS Rhythm DLX Ultrasound Probe, RebuiltSP-DLX200DLX-200-USP-R2020-10-30
00850921007004IntersonGP-C0199-79032017-04-27
00850921007011SeeMoreEC 7.5 MHz99-59312016-08-03
00850921007028SeeMoreGP 3.5 MHz99-59292016-08-03
00850921007035SeeMoreViewBladder 1099-90082016-08-03
00850921007042SeeMoreVC 7.5 MHz99-59302016-08-03
00850921007059SeeMorePI 7.5 MHz99-55442018-03-02
00850921007066SeeMore Software2.0.03 URO98-3517-022016-08-29
00850921007073SeeMoreMV 12 MHz99-59342016-08-22
00850921007080SeeMoreGP 200099-87842016-08-29
00850921007097SeeMoreES 12.0 MHz99-55382016-08-29
00850921007103SeeMore Software2.0.03 GEN98-3517-002016-08-29
00850921007110SeeMore Software2.0.03 OB GYN98-3517-032016-08-29
00850921007127IntersonSP-L0199-79012017-04-27
00850921007134SeeMore ViewBladder 10 Software2.0.03 ViewBladder98-3518-002016-08-29
00850921007141SeeMore Software4.2.1 OB GYN98-3528-012016-08-29
00850921007158SeeMore Software4.2.1 GEN98-3528-022016-08-29
00850921007165SeeMore Software4.2.1 URO98-3528-032016-08-29
00850921007172SeeMore Software4.4.x2017-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYO2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.IYO2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.IYO2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.IYO2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.IYO2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.IYO2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYO2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.IYO2026-01-20