FDA.reportPublic FDA data

AVISO (S)

Primary DI
03700542625002
Brand
AVISO (S)
Company
QUANTEL MEDICAL
Model
AVISO (S)
Device description
AVISO (S) Ophthalmic A (A-Std), B Scan and UBM Ultrasound SystemThe QUANTEL MEDICAL AVISO modular platform is an ultrasound system intended to be used for:• Axial Length measurement of the eye by ultrasonic means• Implanted IOL power calculation, using the Axial Length measurement• Visualization of the interior of the eye and the orbit by A and B scans(• Advanced diagnostic: standardized echography provides detailed information about the internal reflectivity of tissues and allows optimal tissues differentiation, localization and measurement of structures in the eye and orbit.)
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
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

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
03700542625002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700542625002037005426250023700542625002

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities.

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
03700542625057B Probe 10MHz AVISOB1 AVISO2016-09-23
03700542625064B Probe 20MHz AVISOB-HF 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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08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455017MyLabA50ESAOTE SPAIYO2025-07-07
08056304455215MyLabE85ESAOTE SPAIYO2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAIYO2025-07-07
08056304455437MyLabA50ESAOTE SPAIYO2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAIYO2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAIYO2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAIYO2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
08056304455628MyLabE80ESAOTE SPAITX2024-03-29
08056304455628MyLabE80ESAOTE SPAIYO2024-03-29
08056304454980MyLabX90ESAOTE SPAIYO2023-12-14
08056304454980MyLabX90ESAOTE SPAITX2023-12-14
08056304455031MyLabOmega eXPESAOTE SPAIYO2023-12-14
08056304454676MyLabX9ESAOTE SPAITX2023-06-13
08714729982845MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONIYO2021-11-29
08714729982852MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONITX2021-11-29
08714729982869MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONIYO2021-11-29
08714729982869MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONITX2021-11-29
08056304454386MyLabX75ESAOTE SPAIYO2021-09-24
08033737713037THD Procto Software SystemTHD SPAITX2021-07-19