510(k) · Cleared
Recalled · Class II · 2017EyeSuite Imaging
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haag-Streit AG · NFJ System, Image Management, Ophthalmic
Cleared on Sep 10, 2014 as substantially equivalent to K082364 (Topcon Corp., 2008) and 1 other predicate after a 13-day review. Its family tree reaches back 6 generations to 1990. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 10, 2014
- Review
- 13 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K896095 (1990). 10 ancestors in all, the oldest K870039 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 4 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 3 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 2 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 1 generation backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- This deviceK142423 EyeSuite ImagingHaag-Streit AG · 2014
- Descendant · cites it directly · 1 of its ownK161829 Huvitz Imaging SystemHuvitz Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK191615 Huvitz Imaging SystemHuvitz Co., Ltd. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −5 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −4 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −3 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −2 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| −1 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| 0 (this device) | K142423 | EyeSuite Imaging | Haag-Streit AG | 2014 | — |
| +1 | K161829 | Huvitz Imaging System | Huvitz Co., Ltd. | 2017 | — |
| +2 | K191615 | Huvitz Imaging System | Huvitz Co., Ltd. | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or…Summary page 5…TOPCON Corp., 310 Terrace Avenue, Suite 201, Cincinnati OH 45220 510(k) Premarket Notification number: K082364 Device Class: Class II Product Code: NFJ Regulation Number:… | 2008 |
| * | K013694 | Nidek Advanced Vision Information System (Navis)Summary page 4…n Information System (NAVIS) Applicant: NIDEK, Inc., 21911 Erie Ln., Lake Forest, CA 92630 510(k) Premarket Notification number: K013694 Device Class: Class II Product Code: NFJ Regulation Number:… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161829 | Huvitz Imaging System | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 5, 2017 | Class II | Z-1500-2017 | Software design | There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 5.9 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K161829 (Huvitz Co., Ltd., 2017) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K082364.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
EyeSuite Imaging is a software program intended for use for controlling digital imaging devices and for acceptance, transfer, display, storage and digital processing of documentational ophthalmic images and videos, acquired from computerized diagnostic instruments, through direct connection or through networks.
EyeSuite Basic is a patient and examination management system, acting as a base and communication platform for other EyeSuite software components.
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/K142423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142423: EyeSuite Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142423
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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