510(k) · Cleared
Recalled · Class II · 2022CARA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnos, Inc. · NFJ System, Image Management, Ophthalmic
Cleared on Jul 14, 2011 as substantially equivalent to K082364 (Topcon Corp., 2008) after a 107-day review. Its family tree reaches back 6 generations to 1990. It has been recalled once.
- Decided
- Jul 14, 2011
- Review
- 107 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K896095 (1990). 10 ancestors in all, the oldest K870039 (1987). No later device cites it as a predicate yet.
- 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 deviceK110869 CARADiagnos, Inc. · 2011
View 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) | K110869 | CARA | Diagnos, Inc. | 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 |
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? (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 |
|---|---|---|---|
| * | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or…Summary page 1…oprietary name: CARA 3. Predicate Device The predicate device is the Topcon IMAGEnet Professional PC Software System, cleared under K082364. 4. Description of device CARA is a software platform that collects, enhances, stores, and manages color… | 2008 |
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 |
|---|---|---|---|---|
| Jan 11, 2022 | Class II | Z-0826-2022 | No Marketing Application | Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- None of the 10 ancestors has a recall.
- 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. 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?
CARA is a comprehensive software platform intended for importing, processing, and storing of color fundlus images as well as visualization of original and enhanced image through computerized networks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110869 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110869: CARA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110869
Report an extraction error
Are you the manufacturer?
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