OTI Scan with Transducers

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K030770 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Xe-Lite

  Class II

  FDA 510(k) K954263 Active Cleared 18 Oct 1995

• I-Scope Ophthalmic Endoscope

  Class II

  FDA 510(k) K971679 Active Cleared 25 Jun 1997

• Di-Rhex Ophthalmic Diathermy System

  Class II

  FDA 510(k) K990064 Active Cleared 4 Apr 1999

• Hf Module with Transducers

  Class II

  FDA 510(k) K031391 Active Cleared 20 Jun 2003

• I-Scan

  Class II

  FDA 510(k) K960622 Active Cleared 13 May 1996

• A-Scan 100

  Class II

  FDA 510(k) K024114 Active Cleared 10 Jan 2003

See all devices from Ophthalmic Technologies, Inc. →

• What types of eye measurements can the OTI Scan with Transducers perform, and how does it work?

  The OTI Scan with Transducers uses pulsed ultrasound technology to visualize the interior of the eye and conduct biometric measurements. Specifically, it performs axial length assessments via A-scan (using 13 MHz) and B-scan (using 12 MHz) modalities. This allows clinicians to evaluate internal eye structures and dimensions, which is particularly useful for procedures like intraocular lens calculations or diagnosing ocular conditions.

• Is the OTI Scan with Transducers a single-use or reusable device, and what does that mean for my practice?

  The OTI Scan with Transducers is designed as a reusable system, meaning it can be used multiple times after proper cleaning and maintenance. This makes it cost-effective for clinical settings, though your practice will need to follow manufacturer guidelines for disinfection and sterilization to ensure safety and functionality between uses.

• What settings or environments is the OTI Scan with Transducers intended for, and does it require any additional accessories?

  This device is intended for use in radiology settings, specifically for ophthalmic diagnostics. It requires compatible transducers to operate, as the system itself is not a standalone unit but part of a larger ultrasonic imaging setup. The transducers are essential for transmitting and receiving ultrasound waves to perform the scans.

• How is the OTI Scan with Transducers regulated, and what does that mean for purchasing or using it?

  The OTI Scan with Transducers is regulated under the FDA’s 510(k) clearance process, with a clearance number of K030770. It falls under product code IYO (Imaging, Pulsed Echo, Ultrasonic) and was determined to be substantially equivalent to a predicate device by the Radiology Advisory Committee. This means it meets FDA standards for safety and effectiveness, but you should confirm compliance with your facility’s procurement and regulatory policies before use.