510(k) · Cleared
Recalled · Class II · 2016Innova and Innova 2000 S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Oct 8, 2002 as substantially equivalent to K993037 (Ge Medical Systems, Inc., 2000) and 1 other predicate after an 83-day review. Its family tree reaches back 2 generations to 1989. 78 later devices descend from it. It has been recalled 7 times.
- Decided
- Oct 8, 2002
- Review
- 83 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 2 generations to K890348 (1989). 5 ancestors in all. 78 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 1 generation backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- This deviceK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002
- Descendant · cites it directly · 76 of its ownK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- Descendant · cites it directly · 75 of its ownK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- Descendant · 2 generations on · 74 of its ownK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- Descendant · 2 generations on · 47 of its ownK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- Descendant · 3 generations on · 23 of its ownK081582 Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · Recalled
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K031637Innova 3100GE Medical Systems · 2003 · cites it directly76descendants
- K050489Innova 2100Ge Medical Systems, LLC · 2005 · cites it directly75descendants
- K052412Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQGE Healthcare · 2005 · 2 generations on74descendants
- K060259Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · 2 generations on47descendants
- K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · 3 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −1 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| 0 (this device) | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | — |
| +1 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| +1 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| +2 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| +2 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| +3 | K081582 | Infx-8000V, Infinix-Cfi and Infinix Vfi | Toshiba America Medical Systems, In.C | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 10 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K993037 | LCV+ Version 2Summary page 1…GE Medical Systems, Milwaukee, Wi The Digital Fluoroscopic Imaging Systems are substantially equivalent to the currently marketed cardiographic system LCV+ Version 2 (K993037) that complies with the same or equivalent standards. - ‘ The optional Fast Spin rotational angiography feature in the innova 200… | 2000 |
| * | K945375 | Advantx LcaSummary page 1…with the same or equivalent standards. - ‘ The optional Fast Spin rotational angiography feature in the innova 2000 system is substantially equivalent to the LCA system {K945375) for this feature. The Digital Fluoroscopic Imaging System is designed to perform fluoroscopic x-ray examinations. The detector… | 1995 |
| † | K890348 | LC, Cardiac Positioner #B5078A | 1989 |
What descends from it? (78)
See all 783 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2016 | Class II | Z-0904-2017 | Nonconforming Material/Component | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems. |
| Dec 18, 2015 | Class II | Z-0763-2016 | Nonconforming Material/Component | GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor. |
| Aug 16, 2013 | Class II | Z-0021-2014 | Process control | GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular… |
| Jun 10, 2010 | Not classified | Z-2238-2010 | Other | A hardware component (potentiometer and encoder)mismatch in Innova 2000 digital fluoroscopic imaging systems may cause a Source to Image Distance (SID) failure, which will cause the imager to fail to detect the distance between the imager… |
| Dec 22, 2009 | Not classified | Z-0620-2010 | Device Design | Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potential weakness of some table rotational… |
| Jul 25, 2008 | Not classified | Z-2435-2008 | Device Design | The charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down. |
| Mar 6, 2006 | Not classified | Z-0896-06 | Other | Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 11.0 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K031637 (GE Medical Systems, 2003) has gone furthest, with 76 descendants of its own.
- 5 other devices also cite its predicate K993037.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and
interventional cardiac angiography and optionally, rotational cardiac angiography procedures
of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all
diagnostic or interventional cardiac angiography procedures.
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/K022322 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022322: Innova and Innova 2000 S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022322
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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