510(k) · Cleared
Recalled · Class II · 2017Ois Symphony Image Managment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ophthalmic Imaging Systems · NFJ System, Image Management, Ophthalmic
Cleared on May 18, 2011 as substantially equivalent to K090439 (Carl Zeiss Meditec, Inc., 2009) and 2 other predicates after a 135-day review. Its family tree reaches back 7 generations to 1990. It has been recalled 4 times.
- Decided
- May 18, 2011
- Review
- 135 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 7 generations to K896095 (1990). 15 ancestors in all, the oldest K870039 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 5 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 4 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 3 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 2 generations backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- 1 generation backK093313 SynergyTopcon Medical Systems, Inc. · 2009
- This deviceK110006 Ois Symphony Image Managment SystemOphthalmic Imaging Systems · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −6 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −5 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −4 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −3 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| −2 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| −1 | K093313 | Synergy | Topcon Medical Systems, Inc. | 2009 | — |
| 0 (this device) | K110006 | Ois Symphony Image Managment System | Ophthalmic Imaging Systems | 2011 | — |
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 |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090439 | FORUMSummary page 2…Imaging Systems 510(k) Predicate Device: OIS Symphony Image Management System is substantially equivalent to the following predicate devices: (I) Zeiss Forum (K090439) Manufactured by Carl Zeiss Meditec Inc. is intended as a software system in storing, managing, and displaying patient data, diag… | 2009 |
| * | K013694 | Nidek Advanced Vision Information System (Navis)Summary page 2…stic data, videos, and images from computerized diagnostic instruments through networks. (2) Nidek Advanced Vision Information System (NAVIS) (K013694) manufactured by Nidek is a computer technology software that collects, stores, and maintains patient data information; providing… | 2002 |
| * | K093313 | SynergySummary page 2…orkstation. Navis contains core software that can be, augmented by additional software modules, supporting the various applications used clinically. (3) Synergy (K0933 13) Manufactured by Topcon Medical Systems Inc, is a comprehensive software platform intended for use in acquisition or importing, p… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 13, 2017 | Class II | Z-2754-2017 | Software design | When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to delete an image, ECP may then read that image as… |
| Apr 4, 2016 | Class II | Z-1681-2017 | Software Design Change | The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions. |
| Apr 4, 2016 | Class II | Z-1828-2017 | Software in the Use Environment | During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently. |
| Mar 28, 2016 | Class II | Z-1246-2017 | Device Design | Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- None of the 15 ancestors has a recall.
- 4 other devices also cite its predicate K090439.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
OIS Symphony is a comprehensive software platform for the import, integration and review of patient data and clinical information in an eye care environment. OIS Symphony allows for the collection, management, enhancement and review of the patient demographics, image data, diagnostic data and clinical reports from a variety of medical devices through either a direct connection with the instruments or through computerized networks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110006: Ois Symphony Image Managment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110006
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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