510(k) · Cleared
ClearedGE Oec Altitude
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shimadzu Corp. · IZI System, X-Ray, Angiographic
Cleared on Jul 5, 2007 as substantially equivalent to K943545 (Shimadzu Medical Systems, 1995) and 1 other predicate after a 13-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jul 5, 2007
- Review
- 13 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K943545 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK943545 Ceiling Suspended C-Arm Support MH-100Shimadzu Medical Systems · 1995 · Recalled
- This deviceK071717 GE Oec AltitudeShimadzu Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943545 | Ceiling Suspended C-Arm Support MH-100 | Shimadzu Medical Systems | 1995 | 1 |
| 0 (this device) | K071717 | GE Oec Altitude | Shimadzu Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 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.
Planning a device in IZI? 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? (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 |
|---|---|---|---|
| * | K943545 | Ceiling Suspended C-Arm Support MH-100Summary page 1…madzu Corporation PREDICATE DEVICE: Shimadzu Angiosigma NEO which consists of MH-100 (1(943545) and DAR-2400-15B/30B (1(955395). The Official Contact is:… | 1995 |
| * | K955395 | DAR-2400-15B/30BSummary page 1…which consists of MH-100 (1(943545) and DAR-2400-15B/30B (1(955395). The Official Contact is: Mr. Akina Shigeyasu Man… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K943545.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 | — |
What is it indicated for?
This device is intended to be used for generating fluoroscopic images of human anatomy for the diagnostic, surgical and interventional angiography and cardiology procedures of circulatory vascular system.
This device is operated and used by the physicians, X-ray technologist and radiologists.
This device can be used in conjunction with a mobile or fixed surgical table.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071717: GE Oec Altitude.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071717
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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