# K964137: Rta Retinal Thickness Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Talia Technology, Ltd.
- Decided: Feb 3, 1997 after 111 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871268 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930518: Talia Laser Slit, Talia Technology, Ltd. (1994)
- K912891: Heidelberg Retina Tomograph, Heidelberg Engineering (1991) Summary page 2.
- K944523: Humphrey Oct (Optical Coherence Tomography) Scanner, Humphrey, Inc. (1994) Summary page 2.
- K871268: Rodenstock Scanning Laser Ophthalmoscope, G. Rodenstock Instrumente GmbH (1987) Summary page 2.
- K882517: Rodenstock Scanning Laser Ophthalmoscope, Rodenstock Instrument Corp. (1989) Summary page 2.
- K941705: Nerve Fiber Analyzer, Carl Zeiss Meditec, Inc. (1994) Summary page 2.
- K923742: Topographic Scanning System Topss, Carl Zeiss Meditec, Inc. (1993) Summary page 2.
- K913118: Glaucoma-Scope, Ophthalmic Imaging Systems (1991) Summary page 2.

## Indications for use
The RTA is a computerized laser slitlamp biomicroscope that is intended to provide manual and computerized tomography of the retina in vivo. The RTA scans successive slit images on the fundus, without the need for a contact lens, to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. It is indicated for assessing the area and location of retinal thickness abnormalities, such as thickening due to macular edema and atrophy associated with degenerative diseases, and for vxsuahzmg other retinal pathologies.

Source page: https://510kreport.com/device/K964137
Methodology: https://510kreport.com/methodology