510(k) · Cleared
ClearedElectrophysiology Systems Integrator (Epsi)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Systemsone · DXJ Display, Cathode-Ray Tube, Medical
Cleared on Dec 7, 2007 as substantially equivalent to K053356 (Ge Medical Systems Information Technologies, 2006) and 2 other predicates after a 4-day review. Its family tree reaches back 5 generations to 1994. 10 later devices descend from it.
- Decided
- Dec 7, 2007
- Review
- 4 days
- Class
- Class II
- Product code
- DXJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K941811 (1994). 21 ancestors in all, the oldest K822695 (1982). 10 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 4 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 3 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 2 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 1 generation backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- This deviceK073372 Electrophysiology Systems Integrator (Epsi)Systemsone · 2007
- Descendant · cites it directly · 9 of its ownK083321 Cardio-ViewCurlview Igt, LLC · 2008
- Descendant · 2 generations on · 3 of its ownK111320 GlobalcardioCardiocomm Solutions, Inc. · 2011
- Descendant · 3 generations on · 2 of its ownK122632 Guava IICardiocomm Solutions, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK112645 Radiforce Large Monitor SystemEizo GmbH · 2011
- Descendant · 3 generations on · 1 of its ownK172969 Essence 55S Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K083321Cardio-ViewCurlview Igt, LLC · 2008 · cites it directly9descendants
- K111320GlobalcardioCardiocomm Solutions, Inc. · 2011 · 2 generations on3descendants
- K122632Guava IICardiocomm Solutions, Inc. · 2014 · 3 generations on2descendants
- K112645Radiforce Large Monitor SystemEizo GmbH · 2011 · 2 generations on2descendants
- K172969Essence 55S Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −4 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −3 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −2 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −1 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| 0 (this device) | K073372 | Electrophysiology Systems Integrator (Epsi) | Systemsone | 2007 | — |
| +1 | K083321 | Cardio-View | Curlview Igt, LLC | 2008 | — |
| +2 | K111320 | Globalcardio | Cardiocomm Solutions, Inc. | 2011 | — |
| +3 | K122632 | Guava II | Cardiocomm Solutions, Inc. | 2014 | — |
| +2 | K112645 | Radiforce Large Monitor System | Eizo GmbH | 2011 | — |
| +3 | K172969 | Essence 55S Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
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 DXJ? 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 DXJ device
- #1 K261469 Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0…score 12.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K053356 | Modification to: Cic Pro Clinical Information Center Central StationSummary page 1…Product Code: DXJ Equivalent Marketed Device(s): CIC Pro Clinical Information Center Central Station, GE Medical, K053356 HP CareVue 9000, Hewlett-Packard, K992636 Medical Multi… | 2006 |
| * | K992636 | HP Carevue 9000 Clinical Information System, Model M2331ASummary page 1…inical Information Center Central Station, GE Medical, K053356 HP CareVue 9000, Hewlett-Packard, K992636 Medical Multi-Disclosure Workstation, SpaceLabs, K962811… | 1999 |
| * | K962811 | Spacelabs Medical Multi-Disclosure WorkstationSummary page 1…HP CareVue 9000, Hewlett-Packard, K992636 Medical Multi-Disclosure Workstation, SpaceLabs, K962811 Device Description: The EPSI is a video integration system that uses a video… | 1997 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K083321 (Curlview Igt, LLC, 2008) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K053356.
How does its category compare?
All DXJ devicesDXJ Display, Cathode-Ray Tube, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DXJ
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DXJ
130in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXJ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXJ
3in 2025
MAUDE reports naming product code DXJ, 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 | 3 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 8 | 29 |
| 2010 | 2 | — | 1 | 148 |
| 2011 | 4 | 53 | 1 | 129 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 3 | 174 | 0 | 4 |
| 2014 | 4 | 242 | 0 | 13 |
| 2015 | 2 | — | 0 | 15 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 4 | 164 | 0 | 10 |
| 2018 | 4 | 130 | 0 | 3 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 22 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 2 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The EPSI system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments into a single video display. These instruments may be commonly found in the electrophysiology laboratory, cardiac catheterization laboratory or where special or general fluoroscopy is used. Control of the video sources is accomplished using a touchpad device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073372: Electrophysiology Systems Integrator (Epsi).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073372
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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