RTA Model D Retinal Thickness Analyzer

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

510(k) Number

K031312 ↗

FDA Product Code

HLI

FDA applicant

Talia Technology , Ltd.

Device Class

Class II

Regulation

21 CFR Part 886.1570

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• RTA Retinal Thickness Analyzer

  Class II

  FDA 510(k) K964137 Active Cleared 3 Feb 1997

• Rta 5 & Rta Model E Retinal Thickness Analyzer

  Class II

  FDA 510(k) K061674 Active Cleared 23 Aug 2006

• Rta Model D Retinal Thickness Analyzer

  Class II

  FDA 510(k) K041290 Active Cleared 24 May 2004

• RTA Retinal Thickness Analyzer Modification

  Class II

  FDA 510(k) K000731 Active Cleared 31 Mar 2000

• Talia Laser Slit

  Class II

  FDA 510(k) K930518 Active Cleared 25 Jan 1994

• Is the RTA Model D Retinal Thickness Analyzer designed for single-use or can it be reused in a clinical setting?

  The RTA Model D is supplied as a reusable, non-sterile medical instrument. Since it is intended for repeated use in ophthalmic settings, proper cleaning and maintenance procedures must be followed to ensure hygiene and functionality between patients.

• What types of retinal assessments can the RTA Model D perform, and how does it differ from traditional ophthalmoscopy?

  The RTA Model D performs manual and computerized tomography of the retina by scanning successive slit images of the fundus, enabling detailed assessment of retinal thickness and internal structure. Unlike traditional ophthalmoscopy, it provides high-resolution fundus imaging combined with quantitative retinal thickness mapping, which helps in diagnosing and monitoring retinal conditions without requiring a contact lens.

• How is the RTA Model D Retinal Thickness Analyzer powered, and what kind of maintenance might be required?

  The RTA Model D is an AC-powered device, as indicated by its classification as an ophthalmoscope with AC power. While the specifications do not detail maintenance requirements, reusable medical devices typically require regular cleaning, calibration, and periodic servicing to ensure accurate imaging and longevity. Consult the manufacturer’s instructions for specific maintenance protocols.

• What regulatory pathway was followed for the approval of the RTA Model D, and what does this mean for clinicians?

  The RTA Model D holds a Special 510(k) clearance (K031312) under the FDA’s regulatory pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance confirms the device’s safety and effectiveness for its intended use in ophthalmic settings, providing clinicians with confidence in its clinical utility for retinal thickness assessment.