510(k) · Cleared
Recalled · 2004LC, Cardiac Positioner #B5078A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · IZI System, X-Ray, Angiographic
Cleared on Feb 27, 1989 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 of the 332 devices in its family, counting itself, have a Class I recall. 331 later devices descend from it. It has been recalled 5 times.
- Decided
- Feb 27, 1989
- Review
- 35 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 5
- Predicates
- 0
331 later devices descend from it, 1 citing it directly. 10 of the 332 devices in this family, counting this one, have a Class I recall.
- This deviceK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989
- Descendant · cites it directly · 330 of its ownK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 218 of its ownK021021 Modular Angiography System Axiom ArtisSiemens Medical Solutions USA, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 124 of its ownK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
- Descendant · 3 generations on · 114 of its ownK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
- Descendant · 4 generations on · 113 of its ownK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
Showing 5 of 331 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 331 · See all- K993037LCV+ Version 2Ge Medical Systems, Inc. · 2000 · cites it directly330descendants
- K021021Modular Angiography System Axiom ArtisSiemens Medical Solutions USA, Inc. · 2002 · 2 generations on218descendants
- K020055Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · 2 generations on124descendants
- K022899Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · 3 generations on114descendants
- K031333Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · 4 generations on113descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | — |
| +1 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| +2 | K021021 | Modular Angiography System Axiom Artis | Siemens Medical Solutions USA, Inc. | 2002 | 21 |
| +2 | K020055 | Philips Integris Allura 9 with FD Option | Philips Medical Systems | 2002 | 2 |
| +3 | K022899 | Philips Integris Allura Flat Detector Release 1.0 | Philips Medical Systems North America Co. | 2002 | 8 |
| +4 | K031333 | Philips Integris Allura Flat Detector Release 1.2 | Philips Medical Systems North America, Inc. | 2003 | 25 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 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), 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 IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (331)
See all 3311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993037 | LCV+ Version 2 | 2000 | 330 |
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2004 | Not classified | Z-0896-04 | Other | Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox. |
| Mar 24, 2004 | Not classified | Z-0897-04 | Other | Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox. |
| Mar 24, 2004 | Not classified | Z-0898-04 | Other | Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox. |
| Mar 24, 2004 | Not classified | Z-0899-04 | Other | Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox. |
| Mar 24, 2004 | Not classified | Z-0900-04 | Other | Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox. |
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 · 6 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 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 8 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 9 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 · 10 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 · 11 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 · 11 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 · 11 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 11 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?
- Of its descendants, K993037 (Ge Medical Systems, Inc., 2000) has gone furthest, with 330 descendants of its own.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K890348 · printed Nov 4, 2026
Cite this page
510(k) Report. “K890348: LC, Cardiac Positioner #B5078A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K890348
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026