510(k) · Cleared

Cleared

Eigen Dsa 2000

K063846510(k) SpecialCleared Jan 26, 200730-day reviewClass II21 CFR 892.2050

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

Eigen · LLZ System, Image Processing, Radiological

Cleared on Jan 26, 2007 as substantially equivalent to K901956 (Eigen, 1990) after a 30-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided: Jan 26, 2007
Review: 30 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K901956 (1990). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK901956 Digital 8 W/Other Numerical Suffixes (1-9, Etc.)Eigen · 1990
This deviceK063846 Eigen Dsa 2000Eigen · 2007
Descendant · cites it directly · 0 of its ownK082341 DSA 2000EXEigen, LLC · 2008

Most influential descendants

Showing 1 of 1 · See all

K082341DSA 2000EXEigen, LLC · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K901956	Digital 8 W/Other Numerical Suffixes (1-9, Etc.)	Eigen	1990	—
0 (this device)	K063846	Eigen Dsa 2000	Eigen	2007	—
+1	K082341	DSA 2000EX	Eigen, LLC	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K063846, 1990–2008Source: 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 LLZ? 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 LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 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? (1)

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
*	K901956	Digital 8 W/Other Numerical Suffixes (1-9, Etc.) Summary page 1 …DSA 2000 is substantially equivalent to another Eigen Imaging Device: the Digital 8. The DSA 2000 is a modification of Eigen's Digital 8, which was cleared under 510(k) K901956. The modifications made to the DSA 2000 do not alter the intended use or the fundamental scientific technology of the device. Bo…	Eigen	1990	—

Also cleared against K901956: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K082341	DSA 2000EX	Eigen, LLC	2008	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?

Its one ancestor has no recall.
Of its descendants, K082341 (Eigen, LLC, 2008) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K901956.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

Read the full statement (119 words)

The Eigen DSA 2000 product is used in vascular imaging applications. During X-ray exposures, the DSA 2000 is used to acquire video images from the video display chain provided by the X-ray manufacturer's system. The images are stored in the DSA 2000 solid state memory, and written to the hard disk medium. Images are processed in real-time to provide increased image usability. The processing is primarily subtraction, but also includes window and level adjustments, as well as optional noise reduction, landscaping, and pixel shifting. The Eigen DSA 2000 device is used in X-ray cardiology and radiology labs to enhance diagnostic capabilities of radiologists and cardiologists, with minimal intervention required by users to perform basic capture, playback, and archiving functions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063846 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063846: Eigen Dsa 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063846

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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