FDA.reportPublic FDA data

NA

Primary DI
00840682105026
Brand
NA
Company
GE Healthcare Austria GmbH & Co OG
Model
IC9-RS
Catalog number
H48691PJ
Device description
IC9-RS
Published
2016-07-15
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
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
K160162000
K160184000
K180374000
K180535000
K181783000
K201828000
K203114000
K213642000
K213689000
K214039000
K230346000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160162000Voluson P6, Voluson P8GE Healthcare2016-04-26IYN
K160184000Voluson S6, Voluson S8, Voluson S10GE Healthcare2016-02-25IYN
K180374000Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare2018-03-13IYN
K180535000Voluson P6 and Voluson P8GE Healthcare2018-03-29IYN
K181783000LOGIQ P9; LOGIQ P7GE Healthcare2018-09-20IYN
K201828000Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics2020-10-11IYN
K203114000LOGIQ P10, LOGIQ P9, LOGIQ P8GE Medical Systems Ultrasound and Primary Care Diagnostics2021-01-08IYN
K213642000Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare2022-01-13IYN
K213689000Voluson P6, Voluson P8GE Healthcare2022-02-17IYN
K214039000LOGIQ P10, LOGIQ P9, LOGIQ P8GE Medical Systems Ultrasound and Primary Care Diagnostics2022-03-22IYN
K230346000Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC2023-06-20IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682105026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682105026008406821050268406821050260840682105026

GMDN Terms#

Term, Definition table
TermDefinition
Rectal/vaginal ultrasound imaging transducerAn invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
300599979
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682108362NARIC5-9W2016-07-15
00840682118040NARIC5-9-RS2016-07-15
00195278814685VolusonExp BT24 to BT25 UPG59542912025-01-08
00195278770158VolusonExpert 20 BT2559361052025-01-07
00195278770226VolusonExpert 18 BT2559361062025-01-07
00195278770271VolusonExpert 22 BT2559361042025-01-07
00840682117968NA4D10L2016-07-15
00840682107723NARAB4-8L2016-07-15
00840682108324NARIC5-9H2016-07-15
00840682118125NARNA5-92016-07-15
00840682107655NA4DE7C2016-07-15
00840682107716NA4C-A2016-07-15
00840682117920NA4D8C2016-07-15
00840682104890NARRE5-10-D2016-07-15
00840682107600NAAB2-7-RS2016-07-15
00840682107709NAAB2-72016-07-15
00840682118194NARIC5-92016-07-15
00840682118217NARRE6-10-D2016-07-15
00195278677587VolusonExp to BT24 UPG59367972023-11-15
00195278699848VolusonExpert 22 BT2459345522023-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.IYO2026-06-01
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.IYN2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.IYO2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.IYN2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYN2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYN2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYN2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYO2026-05-29
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYN2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.IYN2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
00850055427075HYDROS TRUS ProbePROCEPT BioRobotics CorporationITX2024-09-06
08033737713037THD Procto Software SystemTHD SPAITX2021-07-19
08052461860046Echolight S.p.a.ECHOLIGHT SPAIYO2021-03-05
08056304452658MyLab 9 eXPESAOTE SPAIYN2018-02-19
08056304452658MyLab 9 eXPESAOTE SPAITX2018-02-19
08056304452603MyLabEight eXPESAOTE SPAIYO2017-04-03
08056304452603MyLabEight eXPESAOTE SPAIYN2017-04-03
08056304452610MyLabEightESAOTE SPAITX2017-04-03
08056304452610MyLabEightESAOTE SPAIYO2017-04-03
08056304452597MyLabSeven ESAOTE SPAITX2017-02-24
08056304452597MyLabSeven ESAOTE SPAIYO2017-02-24