510(k) · Cleared
ClearedRta Model D Retinal Thickness Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Talia Technology, Ltd. · HLI Ophthalmoscope, Ac-Powered
Cleared on May 6, 2003 as substantially equivalent to K000731 (Talia Technology, Ltd., 2000) after a 12-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- May 6, 2003
- Review
- 12 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000731 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000731 Modification to Rta Retinal Thickness AnalyzerTalia Technology, Ltd. · 2000
- This deviceK031312 Rta Model D Retinal Thickness AnalyzerTalia Technology, Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000731 | Modification to Rta Retinal Thickness Analyzer | Talia Technology, Ltd. | 2000 | — |
| 0 (this device) | K031312 | Rta Model D Retinal Thickness Analyzer | Talia Technology, Ltd. | 2003 | — |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K000731 | Modification to Rta Retinal Thickness Analyzer | 2000 |
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?
- Its one ancestor has no recall.
How does its category compare?
All HLI devicesHLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HLI
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · HLI
112in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HLI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HLI
2in 2024
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 Model D Retinal Thickness Analyzer (“RTA”) is a computerized 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 retin,a, 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 visualizing other retinal pathologies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031312: Rta Model D Retinal Thickness Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031312
Report an extraction error
Are you the manufacturer?
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