FDA.reportPublic FDA data

NA

Primary DI
00840682118040
Brand
NA
Company
GE Healthcare Austria GmbH & Co OG
Model
RIC5-9-RS
Device description
RIC5-9-RS
Published
2016-07-15
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
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
K131937000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131937000VOLUSON I/EGE Healthcare2013-09-24IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682118040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682118040008406821180408406821180400840682118040

GMDN Terms#

Term, Definition table
TermDefinition
Rectal ultrasound imaging system transducerAn ultrasound imaging transducer assembly specifically designed to be positioned within the rectum either manually or under endoscopic guidance. Included is a variety of single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. Also known as a rectal, transrectal, or prostate probe, it may incorporate a biopsy needle guidance channel as part of the transducer casing or housing assembly design. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
300599979
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953083246VolusonExpert 20 BT2759752552026-10-09
00198953083253VolusonExpert 18 BT2759752562026-10-09
00198953083260VolusonExpert 22 BT2759752542026-10-09
00195278814685VolusonExp BT24 to BT25 UPG59542912025-01-08
00195278770271VolusonExpert 22 BT2559361042025-01-07
00195278347473VolusonExpert 1858712232022-08-16
00195278347480VolusonExpert 2058685732022-08-16
00195278347497VolusonExpert 2258056922022-06-14
00195278016812VolusonE10 BT212020-09-21
00195278016829VolusonE8 BT212020-09-21
00195278016836VolusonE6 BT212020-09-21
00195278077592VolusonE BT20 to BT21 UPG2020-09-21
00195278713322RIC12-DRIC12-D59185802026-07-24
00840682108508NARIC5-9W-RS2016-07-15
00840682108362NARIC5-9W2016-07-15
00195278770158VolusonExpert 20 BT2559361052025-01-07
00195278770226VolusonExpert 18 BT2559361062025-01-07
00840682117968NA4D10L2016-07-15
00840682107723NARAB4-8L2016-07-15
00840682108324NARIC5-9H2016-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYN2026-10-09
00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083246VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYN2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGIYN2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
06948941160022Bladder ScannerMeda Co., LtdIYO2026-10-08
06948941160022Bladder ScannerMeda Co., LtdITX2026-10-08
00855683006821AquaflexPARKER LABORATORIES INCIYO2026-10-01
00855683006845AquaflexPARKER LABORATORIES INCIYO2026-10-01
04719873009510"Esaote MyLabX1" Ultrasound Transducer_Linear ArrayQISDA CORPORATIONITX2026-10-01
04719873009534"Esaote MyLabX1" Ultrasound Transducer_Phased ArrayQISDA CORPORATIONITX2026-10-01
06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITX2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.ITX2026-09-30
08809887550170EdgeFlow UH10CEdgeCare Inc.IYO2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.ITX2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.IYO2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYO2026-09-29
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationITX2026-09-29
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYN2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYN2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SIYN2026-09-21
00198953126073VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953126073VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYO2026-09-21