Ophthalmic A-Scan A-2000 Sonome
510(k) K843696
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843696 | Date26 Feb 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Ophthalmic A-Scan A-2000 Sonome is a Class II pulsed-echo ultrasonic imaging system designed for ophthalmic applications. It employs ultrasound technology to measure intraocular dimensions, such as axial length, anterior chamber depth, and lens thickness, aiding in the diagnosis and management of ocular conditions. This device falls under the nomenclature category of 'System, Imaging, Pulsed Echo, Ultrasonic,' specifically tailored for radiology use in ophthalmology. Its primary function is to provide quantitative ultrasound biometry for preoperative planning and postoperative assessment in eye surgery.
The Ophthalmic A-Scan A-2000 Sonome is intended for use in clinical radiology settings by trained professionals. It is a reusable device, supplied as a standalone ultrasound system with the necessary probes and controls for accurate measurements. The device holds an FDA 510(k) clearance under product code IYO, granted in 1985, and is classified under the regulatory framework for substantially equivalent imaging systems. Storage and maintenance should follow manufacturer guidelines to ensure proper functionality and compliance with regulatory standards.
Other devices from Sonomed Technology, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the Ophthalmic A-Scan A-2000 Sonome?
The Ophthalmic A-Scan A-2000 Sonome is designed to measure intraocular dimensions such as axial length, anterior chamber depth, and lens thickness using pulsed-echo ultrasound technology. These measurements are critical for diagnosing ocular conditions and guiding preoperative planning and postoperative assessment in eye surgery.
How is the Ophthalmic A-Scan A-2000 Sonome supplied and intended for use?
This device is supplied as a standalone ultrasound system, including necessary probes and controls. It is intended for use in clinical radiology settings by trained professionals, such as ophthalmologists or radiologists, to perform quantitative ultrasound biometry.
Is the Ophthalmic A-Scan A-2000 Sonome a single-use or reusable device?
The Ophthalmic A-Scan A-2000 Sonome is a reusable device. Proper storage and maintenance, as outlined by the manufacturer, are essential to ensure its functionality and compliance with regulatory standards over repeated use.
What regulatory clearance does the Ophthalmic A-Scan A-2000 Sonome hold?
The device holds an FDA 510(k) clearance under product code IYO, granted in 1985. It is classified as substantially equivalent to a predicate device under the regulatory framework for imaging systems, specifically within the radiology category.
What specific intraocular measurements does the Ophthalmic A-Scan A-2000 Sonome provide?
The device provides quantitative measurements of axial length, anterior chamber depth, and lens thickness. These measurements are vital for assessing ocular anatomy and aiding in the planning and evaluation of eye surgeries, such as cataract extraction or intraocular lens implantation.