FDA.reportPublic FDA data

B Probe 20MHz AVISO

Primary DI
03700542625064
Brand
B Probe 20MHz AVISO
Company
QUANTEL MEDICAL
Model
B-HF AVISO
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051851000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051851000AVISO OPHTHALMIC ULTRASOUND SYSTEMQuantel Medical2005-08-03IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700542625064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700542625064037005426250643700542625064

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic ultrasound imaging transducerAn ultrasound imaging transducer that is a hand-held device moved over the intact surface of a patient's eye during imaging applications involving the examination of the lens. It may include single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. Typically used with coupling gels to ensure adequate contact with the patient's eye it steers, focuses and detects the ultrasound beam and resulting echoes mechanically or electronically. This group of devices typically includes ultrasound imaging transducers used with A-mode scanning capabilities. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+33(0)473745745contact@quantel-medical.fr

Regulatory Flags#

DUNS number
738574953
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700542625958CAPSULOCAPSULO2025-03-25
03700542626009POCKET IIIPOCKET III2025-03-25
03700542625316SUPRA 577YSUPRA 577Y2016-09-23
03700542625941AXIALISAXIALIS2022-01-05
03700542625569VITRA 2 VITRA 2 2021-12-29
03700542625613VITRA 810VITRA 8102021-12-29
03700542625927EASYRETEASYRET2021-10-19
03700542625132VITRAVITRA2016-09-23
03700542625286SUPRASUPRA2016-09-23
03700542625415VITRA MULTISPOTVMS2016-09-23
03700542625484EASYRETEASYRET2017-09-11
03700542625224532nm Heine Omega IO with integrated adaptorIOH8105322016-09-23
03700542625231532nm adaptor for Keeler Vantage Plus IO (100µ)810532IOVPST2016-09-23
03700542625248Keeler Vantage Plus IOLAFVP22016-12-07
03700542625392577nm Heine Omega 500 IO with integrated adaptorIOH5772016-09-23
03700542625408577nm adaptor for Keeler Vantage Plus IO (100µ)577IOV1002016-09-23
03700542625521ABSOLUABSOLU2019-07-09
03700542625002AVISO (S)AVISO (S)2016-09-23
03700542625057B Probe 10MHz AVISOB1 AVISO2016-09-23
03700542625118A Standardized ProbeStd-A2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.ITX2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.ITX2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.ITX2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
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08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
04719890960269Neo MedicalAco Healthcare Co., Ltd.ITX2024-09-09
00850055427075HYDROS TRUS ProbePROCEPT BioRobotics CorporationITX2024-09-06
04068151012477ACUSON Origin ICE Diagnostic Ultrasound SystemSIEMENS MEDICAL SOLUTIONS USA, INC.ITX2024-08-22
04719890960061Aco SmartcareAco Healthcare Co., Ltd.ITX2024-05-13
08056304455628MyLabE80ESAOTE SPAITX2024-03-29