FDA.reportPublic FDA data

RIC12-D

Primary DI
00195278713322
Brand
RIC12-D
Company
GE Healthcare Austria GmbH & Co OG
Model
RIC12-D
Catalog number
5918580
Device description
RIC12-D
Published
2026-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K252328000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252328000Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics2025-11-24IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278713322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278713322001952787133221952787133220195278713322

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 Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
300599979
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682108508NARIC5-9W-RS2016-07-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04987670106088CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-07-24
00841436122061Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
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
00841436125444CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125819Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125833Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125857Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126045Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126281Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126304Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126656Multi-Purpose Workstation ™ StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126663CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00840432200216BladderScan®VERATHON INCIYO2026-07-22
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112011iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16