510(k) · Cleared
ClearedEyeCTester
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuro-Eye Diagnostic Systems, LLC · QTW Digital Amsler Grid
Cleared on Sep 7, 2022 as substantially equivalent to K180895 (Oculocare Medical AG, 2018) after a 637-day review. Its family tree reaches back 13 generations to 1987.
- Decided
- Sep 7, 2022
- Review
- 637 days
- Class
- Class I
- Product code
- QTW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K864318 (1987). 42 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 9 generations between
- 3 generations backK121738 Myvisiontrack (TM)Vital Art and Science Incorporated · 2013
- 2 generations backK143211 myVision Track Model 005Vital Art and Science Incorporated · 2015
- 1 generation backK180895 AlleyeOculocare Medical AG · 2018
- This deviceK203594 EyeCTesterNeuro-Eye Diagnostic Systems, LLC · 2022
Show all 13 generations
- Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 12 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 11 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 10 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 9 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 8 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 7 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 6 generations backK051470 Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005
- 5 generations backK071564 Motiva Monitor Device Connectivity, Model# 453564036921Philips Medical Systems · 2007
- 4 generations backK091579 Foresee HomeNotal Vision, Ltd. · 2009
- 3 generations backK121738 Myvisiontrack (TM)Vital Art and Science Incorporated · 2013
- 2 generations backK143211 myVision Track Model 005Vital Art and Science Incorporated · 2015
- 1 generation backK180895 AlleyeOculocare Medical AG · 2018
- This deviceK203594 EyeCTesterNeuro-Eye Diagnostic Systems, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −12 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −11 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −10 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −9 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −8 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −7 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −6 | K051470 | Remote Care Management Systems (RCMS) | Bl Healthcare, Inc. | 2005 | — |
| −5 | K071564 | Motiva Monitor Device Connectivity, Model# 453564036921 | Philips Medical Systems | 2007 | — |
| −4 | K091579 | Foresee Home | Notal Vision, Ltd. | 2009 | — |
| −3 | K121738 | Myvisiontrack (TM) | Vital Art and Science Incorporated | 2013 | — |
| −2 | K143211 | myVision Track Model 005 | Vital Art and Science Incorporated | 2015 | — |
| −1 | K180895 | Alleye | Oculocare Medical AG | 2018 | — |
| 0 (this device) | K203594 | EyeCTester | Neuro-Eye Diagnostic Systems, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
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 QTW? 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 |
|---|---|---|---|
| * | K180895 | AlleyeSummary page 5…1 CFR 886.1330 Product Code(s): QTW Classification Advisory Committee: Ophthalmology Predicate Device(s): Alleye (K180895) 1 Device Description: The EyeCTester - Monitoring Application comprises a… | 2018 |
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?
- The line of descent spans 35 years and passes through 11 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 42 ancestors have a recall of any class.
How does its category compare?
All QTW devicesQTW Digital Amsler Grid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QTW
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QTW
Too few QTW 510(k)s in any year since 2007 to give a median.
Recalls per year · QTW
No recall names QTW since 2007.
Adverse event reports per year · QTW
No MAUDE report names QTW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EyeCTester Model iOS is a mobile software as a medical device (SaMD) app for adults ages 22 and above. It is intended to serve as an aid to eyecare providers to monitor and detect central / paracentral visual distortions (maculopathies) as well as central 10-degree visual field scotomas.
EyeCTester is not intended to screen or diagnose, but it is intended to alert a healthcare provider of any changes in a patient's central visual status. The device is intended for both at-home and clinical use. The EyeCTester is indicated to be used only with compatible mobile devices.
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/K203594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203594: EyeCTester.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203594
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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