510(k) · Cleared

Cleared

Eagle System

K912799510(k) TraditionalCleared Dec 18, 1991176-day reviewClass II21 CFR 892.2040

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

Marquette Electronics, Inc. · LMC Camera, Multi Format, Radiological

Cleared on Dec 18, 1991 after a 176-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 300 later devices descend from it.

Decided: Dec 18, 1991
Review: 176 days
Class: Class II
Product code: LMC
Recalls: None
Predicates: 0

300 later devices descend from it, 1 citing it directly.

This deviceK912799 Eagle SystemMarquette Electronics, Inc. · 1991
Descendant · cites it directly · 299 of its ownK955059 Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 RecorderSiemens Medical Solutions USA, Inc. · 1996
Descendant · 2 generations on · 292 of its ownK013515 Infinity ExplorerSiemens Medical Solutions USA, Inc. · 2002
Descendant · 3 generations on · 289 of its ownK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
Descendant · 4 generations on · 280 of its ownK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
Descendant · 5 generations on · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004

Showing 5 of 300 descendants. See all descendants

Descendants cleared per year

1996high 21 (2022) · low 0 (1997)2026

Most influential descendants

Showing 5 of 300 · See all

K955059Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 RecorderSiemens Medical Solutions USA, Inc. · 1996 · cites it directly299descendants
K013515Infinity ExplorerSiemens Medical Solutions USA, Inc. · 2002 · 2 generations on292descendants
K022889Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens…Siemens Medical Solutions USA, Inc. · 2002 · 3 generations on289descendants
K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSiemens Medical Solutions USA, Inc. · 2003 · 4 generations on280descendants
K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · 5 generations on251descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K912799	Eagle System	Marquette Electronics, Inc.	1991	—
+1	K955059	Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 Recorder	Siemens Medical Solutions USA, Inc.	1996	—
+2	K013515	Infinity Explorer	Siemens Medical Solutions USA, Inc.	2002	—
+3	K022889	Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &…	Siemens Medical Solutions USA, Inc.	2002	—
+4	K031340	Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with…	Siemens Medical Solutions USA, Inc.	2003	—
+5	K041956	Emg - Essential Gas Module, Model M1013A	Draeget Medical AG & Co. Kgaa	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2002	4	0
2003	5	0
2004	7	0
2005	10	0
2006	14	0
2007	7	0
2008	5	0
2009	6	0
2010	10	0
2011	11	0
2012	11	0
2013	13	0
2014	11	0
2015	11	0
2016	13	0
2017	13	0
2018	15	0
2019	11	0
2020	11	0
2021	14	0
2022	21	0
2023	21	0
2024	19	0
2025	21	0
2026	15	0

FIG. 1 — Lineage of K912799, 1991–2026Source: 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 LMC? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (300)

See all 300

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

Number	Device	Applicant	Decided	Descendants
K955059	Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 Recorder	Siemens Medical Solutions USA, Inc.	1996	299

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, K955059 (Siemens Medical Solutions USA, Inc., 1996) has gone furthest, with 299 descendants of its own.

How does its category compare?

All LMC devices

LMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMC

2in 2014

2007high 3 (2009) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMC

80in 2009

2007high 80 (2009)2026

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

Recalls per year · LMC

1in 2008

2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LMC

2in 2018

2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code LMC, 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	—	1	0
2009	3	80	0	0
2010	0	—	0	0
2011	1	—	0	0
2012	0	—	0	0
2013	0	—	0	1
2014	2	—	0	1
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	2
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

https://510kreport.com/device/K912799 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912799: Eagle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912799

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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