510(k) Report

510(k) · Cleared

Cleared

Matchedflicker

K090266510(k) TraditionalCleared May 6, 200992-day reviewClass II21 CFR 892.2050

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

Eyeic Corporation · NFJ System, Image Management, Ophthalmic

Cleared on May 6, 2009 as substantially equivalent to K013694 (Nidek, Inc., 2002) and 2 other predicates after a 92-day review. Its family tree reaches back 6 generations to 1990.

Decided
May 6, 2009
Review
92 days
Class
Class II
Product code
NFJ
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K896095 (1990). 11 ancestors in all, the oldest K870039 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor1987: 1 other ancestor2000: 1 other ancestor1996: 1 other ancestor1991: 1 other ancestorK896095 · Images-on-Call Teleradiology System · Devices & Services Co. · 1990K962699 · Radworks Medical Imaging Software · Applicare Medical Imaging, B.V. · 1996K982862 · Radworks Medical Imaging Software with Quality Control Module · Applicare Medical Imaging, B.V. · 1998K012093 · Aetmed Image Processing Software · Aetmed, S.P.A. · 2001K013694 · Nidek Advanced Vision Information System (Navis) · Nidek, Inc. · 2002K082364 · Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for · Topcon Corp. · 2008198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 2 other ancestors5 generations back: 1 other ancestor K082364 · Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for · Topcon Corp. · 2008K013694 · Nidek Advanced Vision Information System (Navis) · Nidek, Inc. · 2002K012093 · Aetmed Image Processing Software · Aetmed, S.P.A. · 2001K982862 · Radworks Medical Imaging Software with Quality Control Module · Applicare Medical Imaging, B.V. · 1998K962699 · Radworks Medical Imaging Software · Applicare Medical Imaging, B.V. · 1996K896095 · Images-on-Call Teleradiology System · Devices & Services Co. · 1990−50
  1. Root · 6 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
  2. 5 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
  3. 4 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
  4. 3 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
  5. 2 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
  6. 1 generation backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
  7. This deviceK090266 MatchedflickerEyeic Corporation · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K896095Images-on-Call Teleradiology SystemDevices & Services Co.1990—
−5K962699Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V.1996—
−4K982862Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V.1998—
−3K012093Aetmed Image Processing SoftwareAetmed, S.P.A.2001—
−2K013694Nidek Advanced Vision Information System (Navis)Nidek, Inc.2002—
−1K082364Imagenet Professional PC Software System or Imagenet Professional, or Imagenet…Topcon Corp.2008—
0 (this device)K090266MatchedflickerEyeic Corporation2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199110
199610
200010
200710
FIG. 1 — Lineage of K090266, 1990–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

Top candidate predicates for a new NFJ device

  1. #1 K260694 Zeiss Clinic 360score 15.0 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K013694Nidek Advanced Vision Information System (Navis)
Summary page 1
…Digital Imaging Software Classification Name: Picture Archiving & Communication System (21 CFR 892.2050. NFJ) Predicate Devices 1. NAVIS by Nidek, Inc. (K013694) 2. Retasure by Digital Healthcare, Inc. (K071299), 3. IMAGEnet by Topcon Corp (K082364) Intended Use…
Nidek, Inc.2002—
*K071299IP System, Oculab IP, Optomize IP, Retasure IP
Summary page 1
…ng & Communication System (21 CFR 892.2050. NFJ) Predicate Devices 1. NAVIS by Nidek, Inc. (K013694) 2. Retasure by Digital Healthcare, Inc. (K071299), 3. IMAGEnet by Topcon Corp (K082364) Intended Use: The MatchedFlicker® device is a software program tha…
Digital Healthcare, Ltd.2007—
*K082364Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or…
Summary page 1
…redicate Devices 1. NAVIS by Nidek, Inc. (K013694) 2. Retasure by Digital Healthcare, Inc. (K071299), 3. IMAGEnet by Topcon Corp (K082364) Intended Use: The MatchedFlicker® device is a software program that is intended for use by health care profes…
Topcon Corp.2008—

Also cleared against K013694: 6 other devices →

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 19 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
  • None of the 11 ancestors has a recall.
  • 6 other devices also cite its predicate K013694.

How does its category compare?

All NFJ devices

NFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NFJ

2in 2024

2007: 12008: 12009: 42011: 22012: 22013: 52014: 22015: 32017: 52018: 72019: 22020: 52021: 22022: 32023: 42024: 22026 (partial year): 2
2007high 7 (2018) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NFJ

85in 2023

2009: 67 days median2013: 73 days median2015: 87 days median2017: 175 days median2018: 84 days median2020: 116 days median2022: 284 days median2023: 85 days median
2007high 284 (2022) · low 67 (2009)2026

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

Recalls per year · NFJ

1in 2024

2010: 22015: 12020: 22022: 12024: 1
2007high 2 (2010) · low 0 (2007)2026

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

Adverse event reports per year · NFJ

2in 2022

2013: 62014: 12015: 22016: 292017: 42019: 22021: 12022: 2
2007high 29 (2016) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
200946700
20100—20
20112—00
20122—00
201357306
20142—01
201538712
20160—029
2017517504
201878400
20192—02
2020511620
20212—01
2022328412
202348500
20242—10
20250—00
20262—0—

What is it indicated for?

The MatchedFlicker device is a software program that is indicated for use by health care professionals to collect, store, and spatially calibrate (i.e. register and align) images of the posterior segment of the human eye.

Indications for use as stated in the FDA summary.

Also cleared against K013694

6 other devices cite the same predicate.

  • K142423EyeSuite ImagingHaag-Streit AG · 20141 recall
  • K110129Righton Zoom Slit Lamp Microscope with Photo OptionRightmedical Products, LLC · 2011
  • K110006Ois Symphony Image Managment SystemOphthalmic Imaging Systems · 20114 recalls
  • K093313SynergyTopcon Medical Systems, Inc. · 2009
  • K090439FORUMCarl Zeiss Meditec, Inc. · 2009
  • K082364Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging…Topcon Corp. · 2008

Recent decisions in NFJ

The NFJ category page

  • K260694Zeiss Clinic 360Carl Zeiss Meditec, AG · 2026
  • K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy · 2026
  • K234076iCare ALTIUS CWCentervue S.P.A. · 2024
  • K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation · 20241 recall
  • K232944CALLISTO eyeCarl Zeiss Meditec, AG · 2023

https://510kreport.com/device/K090266 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090266: Matchedflicker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090266

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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