510(k) · Cleared
Recalled · Class I · 2010Oec 9800 E/CV+ Digital Mobile Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Oec Medical Systems · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Mar 20, 2003 after a 106-day review. The FDA summary names its predicate without a number. 1 of the 60 devices in its family, counting itself, has a Class I recall. 59 later devices descend from it. It has been recalled 20 times, including a Class I recall.
- Decided
- Mar 20, 2003
- Review
- 106 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 20 (1 Class I)
- Predicates
- 0
59 later devices descend from it, 4 citing it directly. 1 of the 60 devices in this family, counting this one, has a Class I recall.
- This deviceK024012 Oec 9800 E/CV+ Digital Mobile Imaging SystemGe Oec Medical Systems · 2003
- Descendant · cites it directly · 40 of its ownK041932 Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 38 of its ownK073543 Oec 9900 EliteGe Oec Medical Systems · 2008 · Recalled
- Descendant · 2 generations on · 35 of its ownK082781 Oec 9900 EliteGe Healthcare Surgery · 2009 · Recalled
- Descendant · 3 generations on · 18 of its ownK120613 Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · Recalled
- Descendant · cites it directly · 18 of its ownK061203 Ziehm Vision R Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006 · Recalled
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K041932Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · cites it directly40descendants
- K073543Oec 9900 EliteGe Oec Medical Systems · 2008 · 2 generations on38descendants
- K082781Oec 9900 EliteGe Healthcare Surgery · 2009 · 2 generations on35descendants
- K120613Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · 3 generations on18descendants
- K061203Ziehm Vision R Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006 · cites it directly18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024012 | Oec 9800 E/CV+ Digital Mobile Imaging System | Ge Oec Medical Systems | 2003 | — |
| +1 | K041932 | Oec Olympus Fluoroscopic Imaging System | Ge Oec Medical Systems, Inc. | 2004 | 7 |
| +2 | K073543 | Oec 9900 Elite | Ge Oec Medical Systems | 2008 | 5 |
| +2 | K082781 | Oec 9900 Elite | Ge Healthcare Surgery | 2009 | 4 |
| +3 | K120613 | Oec 9900 Elite | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012 | 7 |
| +1 | K061203 | Ziehm Vision R Digital Mobile Imaging System | Ziehm Imaging, Inc. | 2006 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 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.
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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 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 |
|---|---|---|---|
| * | — | GE OEC Medical Systems - OEC 9800 Plus Mobile Digital Imaging System Named without a submission number | |
| * | — | Siemens Medical Solutions - Powermobil Named without a submission number |
What descends from it? (59)
See all 594 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 26, 2010 | Class II | Z-2241-2012 | Component change control | GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to the IEC 60601-1 standard for clearance and creepage of voltage isolation. |
| Nov 6, 2009 | Class II | Z-2240-2012 | Device Design | GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer complaint analysis showing that a replacement Hitachi 160 GB Hard Drive, when installed on certain models is susceptible of causing… |
| Oct 10, 2008 | Class II | Z-2262-2012 | Device Design | GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye. |
| Aug 12, 2008 | Not classified | Z-1885-2008 | Radiation Control for Health and Safety Act | Beam limitation may be non-compliant on some X-ray units. |
| Aug 12, 2008 | Not classified | Z-1884-2008 | Radiation Control for Health and Safety Act | Beam limitation may be non-compliant on some X-ray units. |
| Apr 15, 2008 | Not classified | Z-1705-2008 | Device Design | Use of existing four-pedal footswitch on a different machine may cause various operational errors. |
| Feb 22, 2008 | Class I | Z-2038-2012 | Software design | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The vertical lift column power supply in the mainframe C-arm of the device is… |
| Nov 19, 2007 | Class II | Z-2026-2012 | Device Design | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of… |
| Jul 6, 2007 | Not classified | Z-0990-2007 | Other | The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions. |
| Jun 12, 2007 | Not classified | Z-0849-2007 | Other | X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma. |
| Mar 1, 2007 | Not classified | Z-0681-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Mar 1, 2007 | Not classified | Z-0680-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Mar 1, 2007 | Not classified | Z-0677-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Mar 1, 2007 | Not classified | Z-0682-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Feb 9, 2007 | Not classified | Z-0557-2007 | Other | During routine service, a cover may have been installed without the required proper lead shielding. |
| Feb 9, 2007 | Not classified | Z-0556-2007 | Other | During routine service, a cover may have been installed without the required proper lead shielding. |
| Feb 9, 2007 | Not classified | Z-0558-2007 | Other | During routine service, a cover may have been installed without the required proper lead shielding. |
| Feb 9, 2007 | Not classified | Z-0559-2007 | Other | During routine service, a cover may have been installed without the required proper lead shielding. |
| Aug 16, 2006 | Not classified | Z-1302-06 | Other | X-ray systems could provide output which exceeds the 20 R/minute limit. |
| May 31, 2006 | Not classified | Z-0001-2007 | Process control | Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used. |
The 5 latest of 20 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041932 (Ge Oec Medical Systems, Inc., 2004) has gone furthest, with 40 descendants of its own.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The OEC 9800 E/CV+ Digital Mobile Imaging System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. It includes features designed specifically for diagnostic and interventional cardiac imaging procedures, and is also intended for use in cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. It may also be used for other imaging applications at the physician’s discretion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024012: Oec 9800 E/CV+ Digital Mobile Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024012
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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