510(k) · Cleared

Cleared

Discam Digital Imaging System

K974535510(k) TraditionalCleared Aug 14, 1998255-day reviewClass II21 CFR 886.1120

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

Marcher Enterprises, Ltd. · HKI Camera, Ophthalmic, Ac-Powered

Cleared on Aug 14, 1998 as substantially equivalent to K954780 (Kowa Optimed, Inc., 1995) and 3 other predicates after a 255-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it.

Decided: Aug 14, 1998
Review: 255 days
Class: Class II
Product code: HKI
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K912891 (1991). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK912891 Heidelberg Retina TomographHeidelberg Engineering · 1991
This deviceK974535 Discam Digital Imaging SystemMarcher Enterprises, Ltd. · 1998
Descendant · cites it directly · 2 of its ownK102412 Vista Digital OpthalmoscopeEyequick.Llc · 2011
Descendant · 2 generations on · 1 of its ownK121405 PanopticWelch Allyn, Inc. · 2012
Descendant · 3 generations on · 0 of its ownK223381 iExaminer System with Panoptic PlusWelch Allyn, Inc. · 2023

Most influential descendants

Showing 3 of 3 · See all

K102412Vista Digital OpthalmoscopeEyequick.Llc · 2011 · cites it directly2descendants
K121405PanopticWelch Allyn, Inc. · 2012 · 2 generations on1descendant
K223381iExaminer System with Panoptic PlusWelch Allyn, Inc. · 2023 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K912891	Heidelberg Retina Tomograph	Heidelberg Engineering	1991	—
0 (this device)	K974535	Discam Digital Imaging System	Marcher Enterprises, Ltd.	1998	—
+1	K102412	Vista Digital Opthalmoscope	Eyequick.Llc	2011	—
+2	K121405	Panoptic	Welch Allyn, Inc.	2012	—
+3	K223381	iExaminer System with Panoptic Plus	Welch Allyn, Inc.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1993	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2023	1	0

FIG. 1 — Lineage of K974535, 1991–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 HKI? 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 HKI device

#1 K253176 TearViewscore 12.8 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K954780	Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500C Summary page 1 …me: Ophthalmic Digital Camera Classification Name: Camera, Ophthalmic, AC-Powered Predicate Device » KOWA OPTIMED, INC.: KOWA PROFESSIONAL FUNDUS CAMERA MODELS EX-500 (K954780, cleared 12/01/95) ¢ OPHTHALMIC IMAGING SYSTEMS, INC.: DFC-512 DIGITAL IMAGING SYSTEM (K913929, cleared 11/27/91) * LASER DIAGN…	Kowa Optimed, Inc.	1995	—
*	K913929	DFC-1024 & DFC-512 Digital Imaging System Summary page 1 …ice » KOWA OPTIMED, INC.: KOWA PROFESSIONAL FUNDUS CAMERA MODELS EX-500 (K954780, cleared 12/01/95) ¢ OPHTHALMIC IMAGING SYSTEMS, INC.: DFC-512 DIGITAL IMAGING SYSTEM (K913929, cleared 11/27/91) * LASER DIAGNOSTIC TECHNOLOGIES, INC.: TOPOGRAPHIC SCANNING SYSTEM (K923742, cleared 03/26/93) * HEIDELBERG…	Ophthalmic Imaging Systems	1991	5
*	K923742	Topographic Scanning System Topss Summary page 1 …/95) ¢ OPHTHALMIC IMAGING SYSTEMS, INC.: DFC-512 DIGITAL IMAGING SYSTEM (K913929, cleared 11/27/91) * LASER DIAGNOSTIC TECHNOLOGIES, INC.: TOPOGRAPHIC SCANNING SYSTEM (K923742, cleared 03/26/93) * HEIDELBERG ENGINEERING: HEIDELBERG RETINA TOMOGRAPH (K912891, cleared 09/27/91) 510(k) SUMMARY OF SAFETY A…	Carl Zeiss Meditec, Inc.	1993	—
*	K912891	Heidelberg Retina Tomograph Summary page 1 …cleared 11/27/91) * LASER DIAGNOSTIC TECHNOLOGIES, INC.: TOPOGRAPHIC SCANNING SYSTEM (K923742, cleared 03/26/93) * HEIDELBERG ENGINEERING: HEIDELBERG RETINA TOMOGRAPH (K912891, cleared 09/27/91) 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS MARCHER ENTERPRISES, LTD. DISCAM® DIGITAL IMAGING SYSTEM Page 1…	Heidelberg Engineering	1991	—

Also cleared against K954780: 2 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K102412	Vista Digital Opthalmoscope	Eyequick.Llc	2011	2

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?

1 of the 4 ancestors has a recall of any class.
Of its descendants, K102412 (Eyequick.Llc, 2011) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K954780.

How does its category compare?

All HKI devices

HKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HKI

4in 2025

2007high 11 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HKI

167in 2025

2007high 259 (2023) · low 28 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HKI

1in 2018

2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · HKI

1in 2023

2007high 66 (2016) · low 0 (2010)2025

MAUDE reports naming product code HKI, 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	2	—	0	3
2008	5	29	0	1
2009	11	104	0	1
2010	6	140	0	0
2011	7	160	0	0
2012	5	179	1	2
2013	7	141	0	22
2014	4	135	0	3
2015	0	—	0	3
2016	4	146	1	66
2017	2	—	1	20
2018	6	71	1	14
2019	4	73	0	0
2020	5	182	0	5
2021	4	155	0	3
2022	1	—	0	1
2023	5	259	0	1
2024	3	28	0	0
2025	4	167	0	0
2026	2	—	0	—

What is it indicated for?

The Discam® Digital Imaging System is intended to be used to evaluate the Optic Disc, (Optic Nerve Head). It is used in the same fashion as a Fundus camera, except that it's field of view is narrower, in order to focus exclusively on the Optic Disc, (Optic Nerve Head). Evaluation of changes in the size and shape of the Optic Disc, (Optic Nerve Head), is useful in monitoring the progress of patients with Ocular Hypertension, and Glaucoma.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974535 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974535: Discam Digital 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/K974535

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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