Axialis Ophthalmic Ultrasound System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- AXIALIS EUDAMEDFDA UDI
- Generic Name
- Ophthalmic ultrasound imaging system FDA UDI
- Device Name
- AXIALIS EUDAMEDThe AXIALIS Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. • Measurement of corneal thickness by ultrasonic means. FDA UDI
- Model / Reference
- AXIALIS EUDAMEDFDA UDI
- Description
- The AXIALIS Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. • Measurement of corneal thickness by ultrasonic means. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700542625941 EUDAMEDFDA UDI
- Basic UDI-DI
- 37005426AXIALISFT EUDAMED
- 510(k) Number
- FDA Product Code
- IYO FDA 510(k)FDA UDIITX FDA UDI
- EMDN Code
- Z11040107 ECHOPHTHALMOGRAPHS EUDAMED
- GMDN Term
- Ophthalmic ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)FDA UDI892.1570 FDA UDI
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The Axialis Ophthalmic Ultrasound System is a diagnostic ultrasound device classified as an ophthalmic ultrasound system (Device Type: IYO). It performs biometric measurements and imaging of the eye, including axial length and anterior chamber depth, using ultrasound technology. This modality is particularly useful for cases where optical biometry is limited, such as dense cataracts or vitreous hemorrhage.
The system consists of a base unit and interchangeable probes, functioning similarly to the predicate device, the Quantel Medical Compact Touch. It is intended for use in clinical settings, including ophthalmology offices and hospitals, and is supplied as a reusable medical device. The device is authorized under FDA 510(k) clearance (K213254) and MDR compliance, with no explicit sterility or single-use designation in the provided data.
Frequently asked questions
What clinical scenarios is the Axialis Ophthalmic Ultrasound System designed to address in ophthalmology?
The Axialis is specifically designed for cases where traditional optical biometry is unreliable, such as when patients have dense cataracts or vitreous hemorrhage. It provides ultrasound-based imaging and measurements of the eye, including axial length and anterior chamber depth, to aid in diagnostic and preoperative planning.
Is the Axialis Ophthalmic Ultrasound System intended for single-use or reusable applications in clinical settings?
The Axialis is supplied as a reusable medical device, meaning it is intended for repeated use in clinical environments like ophthalmology offices and hospitals. The provided data does not specify any sterility requirements or single-use restrictions, so proper cleaning and maintenance protocols must be followed between uses.
How does the Axialis compare to its predecessor, the Quantel Medical Compact Touch, in terms of functionality?
The Axialis functions similarly to the Compact Touch, maintaining the same core capabilities for biometric measurements and imaging of the eye via ultrasound. The key distinction is its updated design and regulatory compliance, including FDA 510(k) clearance (K213254) and MDR authorization, while retaining the same diagnostic purpose.
What types of facilities can use the Axialis Ophthalmic Ultrasound System, and what are its primary intended uses?
The Axialis is intended for use in clinical settings such as ophthalmology offices and hospitals. Its primary purpose is diagnostic—performing ultrasound-based measurements like axial length and anterior chamber depth to support evaluations where optical methods are limited, ensuring accurate preoperative planning or monitoring of ocular conditions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Quantel Medical AXIalis Ophthalmic Ultrasound System User Manual, AXIalis: the integrated, compact biometer and pachymeter - Lumibird Medical, Axialis Ophthalmic Ultrasound System by Quantel Medical | FDA 510 (k ..., AXIalis: Biometry & Pachymetry from Quantel Medical
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K213254 | Class II | Active |
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Manufacturer
- Manufacturer
- Quantel Medical
Sources (3)
- FDA 510(k) K213254 24 fields · synced Sep 18, 2026
- FDA UDI 4d533ed5-b9dc-461b-9081-1aa380127d60 35 fields · synced May 30, 2026
- EUDAMED d0b5234c-dd5c-40c9-bc60-60f9e4ef6f3e 61 fields · synced Jul 21, 2026