510(k) · Cleared
ClearedGE Oec Everview 7500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Oec Medical Systems, Inc. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Jul 7, 2005 as substantially equivalent to K000221 (Ge Dec Medical Systems, 2000) and 1 other predicate after a 31-day review. Its family tree reaches back 1 generation to 2000. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 7, 2005
- Review
- 31 days
- Class
- Class II
- Product code
- OXO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000221 (2000). 2 ancestors in all. No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK000221 Series 7700 Mobile C-Arm, Compact 7700 Mobile C-Arm, Compact 7700…Ge Dec Medical Systems · 2000 · Recalled
- This deviceK051490 GE Oec Everview 7500Ge Oec Medical Systems, Inc. · 2005
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging Systemdirect predicate · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000221 | Series 7700 Mobile C-Arm, Compact 7700 Mobile C-Arm, Compact 7700 Plus Mobile… | Ge Dec Medical Systems | 2000 | 1 |
| 0 (this device) | K051490 | GE Oec Everview 7500 | Ge Oec Medical Systems, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 1 |
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 OXO device
- #1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 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 |
|---|---|---|---|
| * | K000221 | Series 7700 Mobile C-Arm, Compact 7700 Mobile C-Arm, Compact 7700 Plus Mobile C-ArmSummary page 1…OEC Everview Mobile Digital C-Arm is substantially equivalent to the: * OEC Compact 7700 Mobile C-Arm (K000221) marketed by GE OEC Medical Systems, Inc. * Flexiview 8800 Digi… | 2000 |
| * | K003837 | Flexiview 8800 Digital Mobile Imaging SystemSummary page 1…-Arm (K000221) marketed by GE OEC Medical Systems, Inc. * Flexiview 8800 Digital Mobile Imaging System (K0038371A) marketed by GE OEC Medical Systems, Inc. Summary -… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All OXO devicesOXO Image-Intensified Fluoroscopic X-Ray System, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OXO
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXO
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OXO
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OXO
118in 2025
MAUDE reports naming product code OXO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 48 | 4 | 5 |
| 2013 | 2 | — | 3 | 41 |
| 2014 | 2 | — | 4 | 89 |
| 2015 | 1 | — | 0 | 97 |
| 2016 | 3 | 128 | 3 | 3,820 |
| 2017 | 4 | 57 | 4 | 1,697 |
| 2018 | 1 | — | 11 | 1,647 |
| 2019 | 3 | 213 | 0 | 1,297 |
| 2020 | 0 | — | 0 | 816 |
| 2021 | 2 | — | 0 | 554 |
| 2022 | 0 | — | 0 | 295 |
| 2023 | 0 | — | 0 | 275 |
| 2024 | 2 | — | 4 | 192 |
| 2025 | 4 | 97 | 0 | 118 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The OEC Everview 7500 is a mobile digital C-arm designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical, critical-care and emergency room procedures. Examples of clinical application may include, but are not limited to cholangiography, endoscopy, urology, vascular, orthopedic, neurology and cardiac procedures. It is anticipated that this product will be used on a daily basis by such users, as prescribed by the physician. The system may be used for other imaging applications at the physician's discretion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051490: GE Oec Everview 7500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051490
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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