510(k) · Cleared
ClearedRetina Workplace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · NFJ System, Image Management, Ophthalmic
Cleared on Jun 21, 2017 as substantially equivalent to K150467 (Carl Zeiss Meditec, AG, 2015) and 3 other predicates after a 111-day review. Its family tree reaches back 9 generations to 2002. 2 later devices descend from it.
- Decided
- Jun 21, 2017
- Review
- 111 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K012727 (2002). 51 ancestors in all, the oldest K870039 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 5 generations between
- 3 generations backK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
- 2 generations backK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- 1 generation backK133217 Cirrus PhotoCarl Zeiss Meditec, AG · 2014
- This deviceK170638 Retina WorkplaceCarl Zeiss Meditec, AG · 2017
- Descendant · cites it directly · 0 of its ownK181501 AfinaNeurovision Imaging, LLC · 2018
- Descendant · cites it directly · 0 of its ownK182318 Retina WorkplaceCarl Zeiss Meditec, Inc. · 2018
Show all 9 generations
- Root · 9 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 8 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 7 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 6 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 5 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 4 generations backK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- 3 generations backK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
- 2 generations backK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- 1 generation backK133217 Cirrus PhotoCarl Zeiss Meditec, AG · 2014
- This deviceK170638 Retina WorkplaceCarl Zeiss Meditec, AG · 2017
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 |
|---|---|---|---|---|---|
| −9 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −8 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −7 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −6 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −5 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −4 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| −3 | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and… | Carl Zeiss Meditec, Inc. | 2012 | — |
| −2 | K112184 | Cirrus Photo | Carl Zeiss Meditec, Inc. | 2012 | — |
| −1 | K133217 | Cirrus Photo | Carl Zeiss Meditec, AG | 2014 | — |
| 0 (this device) | K170638 | Retina Workplace | Carl Zeiss Meditec, AG | 2017 | — |
| +1 | K181501 | Afina | Neurovision Imaging, LLC | 2018 | — |
| +1 | K182318 | Retina Workplace | Carl Zeiss Meditec, Inc. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (4)
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 |
|---|---|---|---|
| * | K150467 | Retina WorkplaceSummary page 5…s and Clearances Clearance Substantially Equivalent To: Company Date The Retina Workplace is a K150467 / The Retina Workplace is a Carl Zeiss clinically focused workplace May 21, clinically focused workplace… | 2015 |
| * | K122938 | Forum Forum Archive Forum Archive & Viewer Forum Assist MatchSummary page 5…and is a client of the PACs and is a client of the FORUM server FORUM server. FORUM® is a server based K122938 / The Retina Workplace Carl Zeiss PACs workplace supporting November 2, accessory client for the… | 2012 |
| * | K150977 | Cirrus HD-OctSummary page 5…inically focused generating reports, etc.) and applications. interfaces with DICOM based ophthalmic devices. CIRRUS™ HD-OCT K150977 / The Retina Workplace as a Carl Zeiss containing algorithms for the September 1, clinically focused accessory… | 2015 |
| * | K133217 | Cirrus PhotoSummary page 5…ll Normative edema, and degeneration and Databases other retinopathies. CIRRUS™ Photo K133217 / The Retina Workplace as a Carl Zeiss Combined fundus camera and March 19, clinically focused accessory… | 2014 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 51 ancestors have a recall of any class.
- Of its descendants, K181501 (Neurovision Imaging, LLC, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Retina Workplace is a FORUM application intended for processing and displaying image and optical coherence tomography data. It is also intended for generating reports that contain results from optical coherence tomography and fundus photography.
The Retina Workplace uses CIRRUS algorithms and normative databases as quantitative tool for the comparison of macular thickness data to a database of normal subjects.
The Retina Workplace is intended to aid trained healthcare professionals in the detection, monitoring and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy and age-related macular degeneration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170638: Retina Workplace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170638
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