510(k) · Cleared
Recalled · Class II · 2013LCV+ Version 2
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 Feb 14, 2000 as substantially equivalent to K890348 (General Electric Co., 1989) and 2 other predicates after a 158-day review. Its family tree reaches back 1 generation to 1989. 10 of the 334 devices in its family, counting itself, have a Class I recall. 330 later devices descend from it. It has been recalled 6 times.
- Decided
- Feb 14, 2000
- Review
- 158 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 1 generation to K890348 (1989). 3 ancestors in all. 330 later devices descend from it, 6 citing it directly. 10 of the 334 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- This deviceK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000
- Descendant · cites it directly · 218 of its ownK021021 Modular Angiography System Axiom ArtisSiemens Medical Solutions USA, Inc. · 2002 · Recalled
- Descendant · cites it directly · 124 of its ownK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
- Descendant · 2 generations on · 114 of its ownK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
- Descendant · 3 generations on · 113 of its ownK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
- Descendant · cites it directly · 97 of its ownK023178 Innova 4100Ge Medical Systems, Inc. · 2002 · Recalled
Showing 5 of 330 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 330 · See all- K021021Modular Angiography System Axiom ArtisSiemens Medical Solutions USA, Inc. · 2002 · cites it directly218descendants
- K020055Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · cites it directly124descendants
- K022899Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · 2 generations on114descendants
- K031333Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · 3 generations on113descendants
- K023178Innova 4100Ge Medical Systems, Inc. · 2002 · cites it directly97descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| 0 (this device) | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | — |
| +1 | K021021 | Modular Angiography System Axiom Artis | Siemens Medical Solutions USA, Inc. | 2002 | 21 |
| +1 | K020055 | Philips Integris Allura 9 with FD Option | Philips Medical Systems | 2002 | 2 |
| +2 | K022899 | Philips Integris Allura Flat Detector Release 1.0 | Philips Medical Systems North America Co. | 2002 | 8 |
| +3 | K031333 | Philips Integris Allura Flat Detector Release 1.2 | Philips Medical Systems North America, Inc. | 2003 | 25 |
| +1 | K023178 | Innova 4100 | Ge Medical Systems, Inc. | 2002 | 25 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 11 | 0 |
| 2009 | 7 | 0 |
| 2010 | 12 | 0 |
| 2011 | 10 | 0 |
| 2012 | 14 | 0 |
| 2013 | 16 | 1 |
| 2014 | 19 | 0 |
| 2015 | 15 | 0 |
| 2016 | 17 | 1 |
| 2017 | 12 | 2 |
| 2018 | 27 | 0 |
| 2019 | 11 | 1 |
| 2020 | 19 | 1 |
| 2021 | 17 | 0 |
| 2022 | 20 | 0 |
| 2023 | 15 | 1 |
| 2024 | 19 | 2 |
| 2025 | 29 | 1 |
| 2026 | 21 | 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.
10 devices in this family have 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? (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 |
|---|---|---|---|
| * | K890348 | LC, Cardiac Positioner #B5078ASummary page 1…rue de la Miniére 78530 Buc, France GE Medical Systems, Milwaukee, WI The LCV+ Version 2 is substantially equivalent to the currently marketed LC cardiographic system (K890348), which complies with the same or equivalent standards and has the same intended uses. The digital sub-system, called DL, is subs… | 1989 |
| * | K926258 | DLXSummary page 1…he same or equivalent standards and has the same intended uses. The digital sub-system, called DL, is substantially equivalent to the fluoroscopic digital equipment DLX (K926258 and K945459). The LCV+ Version 2 is designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous… | 1993 |
| * | K945459 | DLXSummary page 1…quivalent standards and has the same intended uses. The digital sub-system, called DL, is substantially equivalent to the fluoroscopic digital equipment DLX (K926258 and K945459). The LCV+ Version 2 is designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with… | 1995 |
What descends from it? (330)
See all 3306 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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… |
| Aug 6, 2009 | Not classified | Z-0393-2011 | Nonconforming Material/Component | GE Healthcare has become aware of a potential video splitter failure with certain Innova 2000 and 4100 X-ray systems that may impact patient safety. A potential video splitter failure inside the GE equipment cabinet could occur with no… |
| Aug 6, 2009 | Not classified | Z-0392-2011 | Nonconforming Material/Component | GE Healthcare has become aware of a potential video splitter failure with certain Innova 2000 and 4100 X-ray systems that may impact patient safety. A potential video splitter failure inside the GE equipment cabinet could occur with no… |
| 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. |
The 5 latest of 6 recalls; the web page lists all.
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.
- K130842Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura Xper FD Biplane…Philips Medical Systems Nederland B.V. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 111 Class I recalls
- K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 9 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 10 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 10 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 10 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K021021 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 218 descendants of its own.
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 LCV+ Version 2 is indicated for use in generating fluoroscopic images of human anatomy for cardiology diagnostic/interventional procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology.
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/K993037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993037: LCV+ Version 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993037
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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