RTA Retinal Thickness Analyzer

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

510(k) Number

K964137 ↗

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 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

• RTA Model D Retinal Thickness Analyzer

  Class II

  FDA 510(k) K031312 Active Cleared 6 May 2003

• What is the RTA Retinal Thickness Analyzer used for?

  The RTA Retinal Thickness Analyzer is designed for the analysis of retinal thickness, providing complete analysis of the macula, peripapillary region, and disc areas, including mapping of retinal thickness, disc topography, digital fundus imaging, and 3D imaging in vivo.

• How is the RTA Retinal Thickness Analyzer supplied and configured?

  The device is supplied as a computerized slitlamp biomicroscope intended to provide manual and computerized tomography of the retina in vivo.

• What regulatory pathway was used for the RTA Retinal Thickness Analyzer?

  The RTA Retinal Thickness Analyzer received FDA 510(k) clearance under K964137 and is classified as a Class II ophthalmic device.