510(k) · Cleared

Cleared

DSA 2000EX

K082341510(k) TraditionalCleared Aug 29, 200814-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, LLC · LLZ System, Image Processing, Radiological

Cleared on Aug 29, 2008 as substantially equivalent to K901956 (Eigen, 1990) and 1 other predicate after a 14-day review. Its family tree reaches back 2 generations to 1990.

Decided: Aug 29, 2008
Review: 14 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K901956 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK901956 Digital 8 W/Other Numerical Suffixes (1-9, Etc.)Eigen · 1990
1 generation backK063846 Eigen Dsa 2000Eigen · 2007
This deviceK082341 DSA 2000EXEigen, LLC · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K901956	Digital 8 W/Other Numerical Suffixes (1-9, Etc.)	Eigen	1990	—
−1	K063846	Eigen Dsa 2000	Eigen	2007	—
0 (this device)	K082341	DSA 2000EX	Eigen, LLC	2008	—

FIG. 1 — Lineage of K082341, 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? (2)

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 …21CFR 892.2050 Predicate Devices: Device Name 510(k) Number Digital 8 K901956 DSA 2000 K063846 Description of the Device and Summary of the Tec…	Eigen	1990	—
*	K063846	Eigen Dsa 2000 Summary page 1 …510(k) Number Digital 8 K901956 DSA 2000 K063846 Description of the Device and Summary of the Technological Characteristics The DSA 2000ex device is used in vascular imaging a…	Eigen	2007	—

Also cleared against K901956: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 18 years and passes through 2 companies; a new generation was cleared every 16.6 years on median.
None of the 2 ancestors has a recall.
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. 2008, 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 (139 words)

The DSA 2000ex device is used in vascular imaging applications. During X-ray exposures, the DSA 2000ex 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 2000ex 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, image rotation and pixel shifting. The Eigen DSA 2000ex 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. Additional functions include allowing measurements to be made for quantizing stenosis and guidance of catheters in the Roadmapping mode.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082341 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082341: DSA 2000EX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082341

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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