510(k) · Cleared
ClearedIris Intelligent Retinal Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Retinal Imaging Systems, LLC · NFJ System, Image Management, Ophthalmic
Cleared on Feb 27, 2015 as substantially equivalent to K113696 (Optos Plc., 2012) and 1 other predicate after a 226-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Feb 27, 2015
- Review
- 226 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K896095 (1990). 17 ancestors in all, the oldest K870039 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 6 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 5 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 4 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 3 generations backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- 2 generations backK093313 SynergyTopcon Medical Systems, Inc. · 2009
- 1 generation backK122938 Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · Recalled
- This deviceK141922 Iris Intelligent Retinal Imaging SystemIntelligent Retinal Imaging Systems, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −7 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −6 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −5 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −4 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| −3 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| −2 | K093313 | Synergy | Topcon Medical Systems, Inc. | 2009 | — |
| −1 | K122938 | Forum Forum Archive Forum Archive & Viewer Forum Assist Match | Carl Zeiss Meditec, AG | 2012 | 1 |
| 0 (this device) | K141922 | Iris Intelligent Retinal Imaging System | Intelligent Retinal Imaging Systems, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 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 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 K260694 Zeiss Clinic 360score 15.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K113696 | Optos AdvanceSummary page 4…Systems as Class II devices pursuant to 21 C.F.R. §892.2050. PRODUCT CODE: CLASSIFICATION / CFR TITLE NFJ, 21 CFR 892.2050 PREDICATE DEVICES Optos Advance Software (K113696) Zeiss Forum (K122938) INDICATIONS FOR USE The IRIS Intelligent Retinal Imaging Systems is a comprehensive web-ba… | 2012 |
| * | K122938 | Forum Forum Archive Forum Archive & Viewer Forum Assist MatchSummary page 4…evices pursuant to 21 C.F.R. §892.2050. PRODUCT CODE: CLASSIFICATION / CFR TITLE NFJ, 21 CFR 892.2050 PREDICATE DEVICES Optos Advance Software (K113696) Zeiss Forum (K122938) INDICATIONS FOR USE The IRIS Intelligent Retinal Imaging Systems is a comprehensive web-based software system ap… | 2012 |
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 25 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 17 ancestors has a recall of any class.
- 1 other device also cites its predicate K113696.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NFJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NFJ
85in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFJ
2in 2022
MAUDE reports naming product code NFJ, 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 | 1 | — | 0 | 0 |
| 2009 | 4 | 67 | 0 | 0 |
| 2010 | 0 | — | 2 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 5 | 73 | 0 | 6 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 3 | 87 | 1 | 2 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 5 | 175 | 0 | 4 |
| 2018 | 7 | 84 | 0 | 0 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 5 | 116 | 2 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 284 | 1 | 2 |
| 2023 | 4 | 85 | 0 | 0 |
| 2024 | 2 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The IRIS Intelligent Retinal Imaging Systems is a comprehensive web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data and images from computerized diagnostic instruments or systems. Original and color amplified images can be viewed by trained healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141922: Iris Intelligent Retinal Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141922
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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