510(k) · Cleared

Cleared

Imagenet Digital Ophthalmic Imaging System

K870039510(k) TraditionalCleared Feb 12, 198738-day reviewClass I21 CFR 870.2810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Par Microsystems Corp. · DSF Recorder, Paper Chart

Cleared on Feb 12, 1987 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 56 later devices descend from it.

Decided: Feb 12, 1987
Review: 38 days
Class: Class I
Product code: DSF
Recalls: None
Predicates: 0

56 later devices descend from it, 5 citing it directly.

This deviceK870039 Imagenet Digital Ophthalmic Imaging SystemPar Microsystems Corp. · 1987
Descendant · cites it directly · 50 of its ownK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
Descendant · 2 generations on · 29 of its ownK093313 SynergyTopcon Medical Systems, Inc. · 2009
Descendant · 3 generations on · 25 of its ownK122938 Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · Recalled
Descendant · 2 generations on · 13 of its ownK101861 Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010
Descendant · 3 generations on · 9 of its ownK132667 Synergy OdmTopcon Medical Systems, Inc. · 2013

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

1997high 7 (2018) · low 0 (1998)2026

Most influential descendants

Showing 5 of 56 · See all

K082364Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or…Topcon Corp. · 2008 · cites it directly50descendants
K093313SynergyTopcon Medical Systems, Inc. · 2009 · 2 generations on29descendants
K122938Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · 3 generations on25descendants
K101861Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010 · 2 generations on13descendants
K132667Synergy OdmTopcon Medical Systems, Inc. · 2013 · 3 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K870039	Imagenet Digital Ophthalmic Imaging System	Par Microsystems Corp.	1987	—
+1	K082364	Imagenet Professional PC Software System or Imagenet Professional, or Imagenet…	Topcon Corp.	2008	—
+2	K093313	Synergy	Topcon Medical Systems, Inc.	2009	—
+3	K122938	Forum Forum Archive Forum Archive & Viewer Forum Assist Match	Carl Zeiss Meditec, AG	2012	1
+2	K101861	Truevision 3D Visualization and Guidance System	Truevision Systems, Incorporated	2010	—
+3	K132667	Synergy Odm	Topcon Medical Systems, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	1	0
2002	2	0
2008	1	0
2009	2	0
2010	2	0
2011	2	0
2012	1	0
2013	4	0
2014	4	0
2015	4	0
2017	4	0
2018	7	0
2019	3	0
2020	4	0
2021	1	0
2022	3	0
2023	5	0
2024	2	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K870039, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DSF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (56)

See all 56

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K082364	Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or…	Topcon Corp.	2008	50
K022164	Zeta Diagnostic Retinal Imaging System	Zeta Development Laboratories	2002	1
K020888	Fundus Autoimager	Visual Pathways, Inc.	2002	0
K990205	Digiscope Ophthalmic Camera	Eye Tel Imaging, Inc.	1999	0
K973950	Retinal Cube	Applied Spectral Imaging, Ltd.	1997	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?

Of its descendants, K082364 (Topcon Corp., 2008) has gone furthest, with 50 descendants of its own.

How does its category compare?

All DSF devices

DSF Recorder, Paper Chart: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSF

FDA has decided no DSF device since 2007.

Median 510(k) review, days · DSF

Too few DSF 510(k)s in any year since 2007 to give a median.

Recalls per year · DSF

1in 2015

2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSF

1in 2012

2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code DSF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	1
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	1
2012	—	0	1
2013	—	0	0
2014	—	0	0
2015	—	1	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

https://510kreport.com/device/K870039 · printed Nov 5, 2026

Cite this page

510(k) Report. “K870039: Imagenet Digital Ophthalmic Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K870039

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026