510(k) · Cleared

Cleared

Rta Retinal Thickness Analyzer

K964137510(k) TraditionalCleared Feb 3, 1997111-day reviewClass II21 CFR 886.1570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Talia Technology, Ltd. · HLI Ophthalmoscope, Ac-Powered

Cleared on Feb 3, 1997 as substantially equivalent to K930518 (Talia Technology, Ltd., 1994) and 7 other predicates after a 111-day review. Its family tree reaches back 1 generation to 1987.

Decided: Feb 3, 1997
Review: 111 days
Class: Class II
Product code: HLI
Recalls: None
Predicates: 8

Its longest line of descent runs back 1 generation to K871268 (1987). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK871268 Rodenstock Scanning Laser OphthalmoscopeG. Rodenstock Instrumente GmbH · 1987
This deviceK964137 Rta Retinal Thickness AnalyzerTalia Technology, Ltd. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K871268	Rodenstock Scanning Laser Ophthalmoscope	G. Rodenstock Instrumente GmbH	1987	—
0 (this device)	K964137	Rta Retinal Thickness Analyzer	Talia Technology, Ltd.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	2	0
1993	1	0
1994	3	0

FIG. 1 — Lineage of K964137, 1987–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HLI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (8)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K930518	Talia Laser Slit	Talia Technology, Ltd.	1994	—
*	K912891	Heidelberg Retina Tomograph Summary page 2 …red slitlamp biomicroscope Predicate Devices Talia’s Laser Slit™ Slit Lamp Attachment '(K9k305 18) Heidelberg Engineering’s Heidelberg Retina Tomograph (K912891) Humphrey Instruments’ Optical Coherence Tomography (OCT) System (K944523) Rodenstock Instrument’s Scanning Laser Ophthalmoscope…	Heidelberg Engineering	1991	—
*	K944523	Humphrey Oct (Optical Coherence Tomography) Scanner Summary page 2 …Slit™ Slit Lamp Attachment '(K9k305 18) Heidelberg Engineering’s Heidelberg Retina Tomograph (K912891) Humphrey Instruments’ Optical Coherence Tomography (OCT) System (K944523) Rodenstock Instrument’s Scanning Laser Ophthalmoscope (K871268 and K882517) Laser Diagnostic Technologies, Inc.’s Nerve Fiber A…	Humphrey, Inc.	1994	—
*	K871268	Rodenstock Scanning Laser Ophthalmoscope Summary page 2 …s Heidelberg Retina Tomograph (K912891) Humphrey Instruments’ Optical Coherence Tomography (OCT) System (K944523) Rodenstock Instrument’s Scanning Laser Ophthalmoscope (K871268 and K882517) Laser Diagnostic Technologies, Inc.’s Nerve Fiber Analyzer (K941705) Laser Diagnostic Technologies, Inc.’s Topograp…	G. Rodenstock Instrumente GmbH	1987	—
*	K882517	Rodenstock Scanning Laser Ophthalmoscope Summary page 2 …Retina Tomograph (K912891) Humphrey Instruments’ Optical Coherence Tomography (OCT) System (K944523) Rodenstock Instrument’s Scanning Laser Ophthalmoscope (K871268 and K882517) Laser Diagnostic Technologies, Inc.’s Nerve Fiber Analyzer (K941705) Laser Diagnostic Technologies, Inc.’s Topographic Scanning…	Rodenstock Instrument Corp.	1989	—
*	K941705	Nerve Fiber Analyzer Summary page 2 …mography (OCT) System (K944523) Rodenstock Instrument’s Scanning Laser Ophthalmoscope (K871268 and K882517) Laser Diagnostic Technologies, Inc.’s Nerve Fiber Analyzer (K941705) Laser Diagnostic Technologies, Inc.’s Topographic Scanning System TOPSS (923742) Ophthalmic Imaging Systems, Inc.’s Glaucoma Sc…	Carl Zeiss Meditec, Inc.	1994	—
*	K923742	Topographic Scanning System Topss Summary page 2 …ope (K871268 and K882517) Laser Diagnostic Technologies, Inc.’s Nerve Fiber Analyzer (K941705) Laser Diagnostic Technologies, Inc.’s Topographic Scanning System TOPSS (923742) Ophthalmic Imaging Systems, Inc.’s Glaucoma Scope (K913118) Intended Use The RTA is a computerized laser slitlamp biomicroscop…	Carl Zeiss Meditec, Inc.	1993	—
*	K913118	Glaucoma-Scope Summary page 2 …nc.’s Nerve Fiber Analyzer (K941705) Laser Diagnostic Technologies, Inc.’s Topographic Scanning System TOPSS (923742) Ophthalmic Imaging Systems, Inc.’s Glaucoma Scope (K913118) Intended Use The RTA is a computerized laser slitlamp biomicroscope that is intended to provide manual and computerized tomogr…	Ophthalmic Imaging Systems	1991	—

Also cleared against K930518: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 8 ancestors has a recall.
1 other device also cites its predicate K930518.

How does its category compare?

All HLI devices

HLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HLI

1in 2016

2007high 4 (2014) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HLI

112in 2014

2007high 112 (2014) · low 36 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HLI

1in 2021

2007high 2 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HLI

2in 2024

2007high 2 (2023) · low 0 (2007)2025

MAUDE reports naming product code HLI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	0	—	1	1
2009	0	—	1	1
2010	2	—	0	0
2011	3	36	0	0
2012	2	—	0	0
2013	2	—	0	1
2014	4	112	0	0
2015	2	—	0	0
2016	1	—	0	0
2017	0	—	2	0
2018	0	—	0	1
2019	0	—	0	0
2020	0	—	0	1
2021	0	—	1	0
2022	0	—	0	1
2023	0	—	0	2
2024	0	—	0	2
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K964137 · printed Nov 5, 2026

Cite this page

510(k) Report. “K964137: Rta Retinal Thickness Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964137

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026