510(k) · Cleared
ClearedAfina
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurovision Imaging, LLC · NFJ System, Image Management, Ophthalmic
Cleared on Nov 2, 2018 as substantially equivalent to K170638 (Carl Zeiss Meditec, AG, 2017) after a 148-day review. Its family tree reaches back 10 generations to 2002.
- Decided
- Nov 2, 2018
- Review
- 148 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K012727 (2002). 52 ancestors in all, the oldest K870039 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 6 generations between
- 3 generations backK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- 2 generations backK133217 Cirrus PhotoCarl Zeiss Meditec, AG · 2014
- 1 generation backK170638 Retina WorkplaceCarl Zeiss Meditec, AG · 2017
- This deviceK181501 AfinaNeurovision Imaging, LLC · 2018
Show all 10 generations
- Root · 10 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 9 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 8 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 7 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 6 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 5 generations backK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- 4 generations backK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
- 3 generations backK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- 2 generations backK133217 Cirrus PhotoCarl Zeiss Meditec, AG · 2014
- 1 generation backK170638 Retina WorkplaceCarl Zeiss Meditec, AG · 2017
- This deviceK181501 AfinaNeurovision Imaging, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −9 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −8 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −7 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −6 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −5 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| −4 | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and… | Carl Zeiss Meditec, Inc. | 2012 | — |
| −3 | K112184 | Cirrus Photo | Carl Zeiss Meditec, Inc. | 2012 | — |
| −2 | K133217 | Cirrus Photo | Carl Zeiss Meditec, AG | 2014 | — |
| −1 | K170638 | Retina Workplace | Carl Zeiss Meditec, AG | 2017 | — |
| 0 (this device) | K181501 | Afina | Neurovision Imaging, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 7 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K170638 | Retina WorkplaceSummary page 4…ent, Ophthalmic Product Code: NFJ Device Class: Class II 3 PREDICATE DEVICE (21 CFR §807.92(A) (3)) Predicate Device: Zeiss Retina Workplace, K170638 This predicate has not been subject to a design-related recall. NeuroVision Imaging… | 2017 |
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 16 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 52 ancestors have a recall of any class.
- 1 other device also cites its predicate K170638.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Afina software is intended for importing, processing and displaying of retinal images and for the measurement of autofluorescence in the superior field (a circular 50-degree field of view at 20 degrees above fixation) of the retina. Afina is indicated for use only with images collected with validated ophthalmic cameras.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181501: Afina.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181501
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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