510(k) · Cleared
ClearedForum Glaucoma 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 Oct 3, 2014 as substantially equivalent to K130648 (Carl Zeiss Meditec, AG, 2013) and 3 other predicates after a 137-day review. Its family tree reaches back 9 generations to 1990. 1 later device descends from it.
- Decided
- Oct 3, 2014
- Review
- 137 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K896095 (1990). 51 ancestors in all, the oldest K870039 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations between
- 3 generations backK093313 SynergyTopcon Medical Systems, Inc. · 2009
- 2 generations backK122938 Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · Recalled
- 1 generation backK130648 Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG · 2013
- This deviceK141297 Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG · 2014
- Descendant · cites it directly · 0 of its ownK200954 Glaucoma ModuleTopcon Healthcare Solutions, Inc. · 2020
Show all 9 generations
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 8 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 7 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 6 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 5 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 4 generations backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- 3 generations backK093313 SynergyTopcon Medical Systems, Inc. · 2009
- 2 generations backK122938 Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · Recalled
- 1 generation backK130648 Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG · 2013
- This deviceK141297 Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG · 2014
Most influential descendants
Showing 1 of 1 · See all- K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −8 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −7 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −6 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −5 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| −4 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| −3 | K093313 | Synergy | Topcon Medical Systems, Inc. | 2009 | — |
| −2 | K122938 | Forum Forum Archive Forum Archive & Viewer Forum Assist Match | Carl Zeiss Meditec, AG | 2012 | 1 |
| −1 | K130648 | Forum Glaucoma Workplace | Carl Zeiss Meditec, AG | 2013 | — |
| 0 (this device) | K141297 | Forum Glaucoma Workplace | Carl Zeiss Meditec, AG | 2014 | — |
| +1 | K200954 | Glaucoma Module | Topcon Healthcare Solutions, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (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 |
|---|---|---|---|
| * | K130648 | Forum Glaucoma WorkplaceSummary page 5…K) SUMMARY PREDICATE DEVICES: Company: Carl Zeiss Meditec AG Device: FORUM Glaucoma Workplace (K130648) Company: Carl Zeiss Meditec AG Device: FORUM (K122938)… | 2013 |
| * | K122938 | Forum Forum Archive Forum Archive & Viewer Forum Assist MatchSummary page 5…Workplace (K130648) Company: Carl Zeiss Meditec AG Device: FORUM (K122938) Company: Carl Zeiss Meditec, Inc. Device: Cirrus HD-OCT with Retinal Nerve Fiber Lay… | 2012 |
| * | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Summary page 5…D-OCT with Retinal Nerve Fiber Layer (RNFL), Macular, Optic Nerve Head and Ganglion Cell Normative Databases (K111157) Company: Carl Zeiss Meditec AG Device CIRRUS photo (K… | 2012 |
| * | K112184 | Cirrus PhotoSummary page 5…es (K111157) Company: Carl Zeiss Meditec AG Device CIRRUS photo (K112184) INDICATIONS FOR USE FORUM Glaucoma Workplace is a FORUM software application intended for the management, display, and analy… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200954 | Glaucoma Module | 2020 | 0 |
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 24 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 51 ancestors have a recall of any class.
- Of its descendants, K200954 (Topcon Healthcare Solutions, Inc., 2020) 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. 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?
FORUM Glaucoma Workplace is a FORUM software application intended for the management, display, and analysis of visual field and optical coherence tomography data. The FORUM Glaucoma Workplace is indicated as an aid to the detection, measurement, and management of visual field defects and progression of visual field loss. FORUM Glaucoma Workplace is also intended for generating reports that contain results from perimetry, optical coherence tomography and…
Read the full statement (109 words)
FORUM Glaucoma Workplace is a FORUM software application intended for the
management, display, and analysis of visual field and optical coherence tomography data. The FORUM
Glaucoma Workplace is indicated as an aid to the detection, measurement, and management of
visual field defects and progression of visual field loss.
FORUM Glaucoma Workplace is also intended for generating reports that contain results
from perimetry, optical coherence tomography and fundus photography.
FORUM Glaucoma Workplace implements Cirrus algorithms and normative databases
for retinal nerve fiber layer thickness, ganglion cell plus inner plexiform thickness and
optic nerve head measurement and Humphrey Field Analyzer algorithms and databases
for visual field measurements and Guided Progression Analysis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141297 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141297: Forum Glaucoma Workplace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141297
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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