510(k) · Cleared
Recalled · Class II · 2011GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · OWB Interventional Fluoroscopic X-Ray System
Cleared on Aug 25, 2009 as substantially equivalent to K052412 (GE Healthcare, 2005) and 5 other predicates after a 54-day review. Its family tree reaches back 11 generations to 1993. 1 of the 83 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times.
- Decided
- Aug 25, 2009
- Review
- 54 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 11 generations to K926514 (1993). 82 ancestors in all, the oldest K882061 (1988). No later device cites it as a predicate yet. 1 of the 83 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 7 generations between
- 3 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 1 generation backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- This deviceK092004 GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model…GE Healthcare · 2009
Show all 11 generations
- Root · 11 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 10 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 9 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 8 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 7 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 6 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 5 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 4 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 3 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 1 generation backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- This deviceK092004 GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model…GE Healthcare · 2009
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…9 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −10 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −9 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −8 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −7 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −6 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −5 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −4 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −3 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −2 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −1 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| 0 (this device) | K092004 | GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ… | GE Healthcare | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 10 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 7 | 0 |
| 2003 | 10 | 1 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 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.
1 device in this family has a Class I recall. 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? (6)
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 |
|---|---|---|---|
| * | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQSummary page 1…33130704399 Innova 4100, 3100, 2100' with StentViz Innova 4100'°, 3100', 2100'? with StentViz System X-F!ay, Angiographic : OWR, JAk, 121 innova 41oo'°. 3100, 21oo'° K052412, KO050489, K060259, K061163 IC-PRO device (K083745) featuring StentOp - Philips Fresco release 1 (featuring StentBoost) (K03183… | 2005 |
| * | K050489 | Innova 2100Summary page 1…Innova 4100, 3100, 2100' with StentViz Innova 4100'°, 3100', 2100'? with StentViz System X-F!ay, Angiographic : OWR, JAk, 121 innova 41oo'°. 3100, 21oo'° K052412, KO050489, K060259, K061163 IC-PRO device (K083745) featuring StentOp - Philips Fresco release 1 (featuring StentBoost) (K031836) The In… | 2005 |
| * | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Summary page 1…4100, 3100, 2100' with StentViz Innova 4100'°, 3100', 2100'? with StentViz System X-F!ay, Angiographic : OWR, JAk, 121 innova 41oo'°. 3100, 21oo'° K052412, KO050489, K060259, K061163 IC-PRO device (K083745) featuring StentOp - Philips Fresco release 1 (featuring StentBoost) (K031836) The Innova 4100… | 2006 |
| * | K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ…Summary page 1…00, 2100' with StentViz Innova 4100'°, 3100', 2100'? with StentViz System X-F!ay, Angiographic : OWR, JAk, 121 innova 41oo'°. 3100, 21oo'° K052412, KO050489, K060259, K061163 IC-PRO device (K083745) featuring StentOp - Philips Fresco release 1 (featuring StentBoost) (K031836) The Innova 4100/, 3100',… | 2006 |
| * | K083745 | The IC-Pro System, Model Version 3.2Summary page 1…Innova 4100'°, 3100', 2100'? with StentViz System X-F!ay, Angiographic : OWR, JAk, 121 innova 41oo'°. 3100, 21oo'° K052412, KO050489, K060259, K061163 IC-PRO device (K083745) featuring StentOp - Philips Fresco release 1 (featuring StentBoost) (K031836) The Innova 4100/, 3100', 2100" Systems are modif… | 2009 |
| * | K031836 | Philips Fresco Release 1Summary page 1…JAk, 121 innova 41oo'°. 3100, 21oo'° K052412, KO050489, K060259, K061163 IC-PRO device (K083745) featuring StentOp - Philips Fresco release 1 (featuring StentBoost) (K031836) The Innova 4100/, 3100', 2100" Systems are modified with an optional software feature called StentViz. The StentViz feature enh… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 24, 2011 | Not classified | Z-0133-2012 | Nonconforming Material/Component | A potential weakness on the monitor suspension end-stop device may impact user safety. The end-stops may break if the monitor-suspension is repeatedly pushed with excessive force on the end rails. |
| Feb 4, 2011 | Class II | Z-0934-2013 | Nonconforming Material/Component | Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable leave an area potentially unprotected. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 9 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 30 of the 82 ancestors have a recall of any class; 1 has a Class I recall.
- 7 other devices also cite its predicate K052412.
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. 2009, this device’s year, is highlighted.
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 Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.
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/K092004 · printed Nov 3, 2026
Cite this page
510(k) Report. “K092004: GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K092004
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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