Aviso (s)

FDA UDI

Class II (US FDA UDI)

by Quantel Medical

Identity

Trade Name: AVISO (S) FDA UDI
Generic Name: Ophthalmic ultrasound imaging system FDA UDI
Device Name: AVISO (S) Ophthalmic A (A-Std), B Scan and UBM Ultrasound System The 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.) FDA UDI
Model / Reference: AVISO (S) FDA UDI
Description: AVISO (S) Ophthalmic A (A-Std), B Scan and UBM Ultrasound System The 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.) FDA UDI

Identifiers

Primary DI / UDI-DI: 03700542625002 FDA UDI
510(k) Number: K051851 FDA UDI
FDA Product Code: ITX FDA UDI
IYO FDA UDI
GMDN Term: Ophthalmic ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
892.1560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Ophthalmic ultrasound imaging system

Aviso (s) by Quantel Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic ultrasound imaging system.

A-scan probe — Nidek, Inc. · Class II
ArcScan Insight 100 — Arcscan, Inc. · Class II
Ultrasonic A/B Scanner for Ophthalmology — Meda , Ltd. · Class II
Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II
Ellex — ELLEX MEDICAL PTY LTD · Class II
LIGHTSonic B UBM — Light-Med(Usa), Inc. · Class II
Ophthalmic Ultrasound Examination Instrument — CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD · Class II
B-scan Plus- VET — ACCUTOME, INC. · Class II

Cleared under the same submission

K051851 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Quantel Medical

Sources (1)

FDA UDI 97c42063-fcba-41d5-b4d9-16fde32a2ff8 35 fields · synced May 30, 2026