510(k) · Cleared
ClearedE-CUBE 9
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alpinion Medical Systems Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Mar 16, 2012 as substantially equivalent to K060993 (General Electric Co., 2006) after a 67-day review. Its family tree reaches back 4 generations to 2001. 23 later devices descend from it.
- Decided
- Mar 16, 2012
- Review
- 67 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010329 (2001). 23 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK010329 LOGIQ 500General Electric Co. · 2001
- 3 generations backK014097 GE Logiq 5GE Medical Systems · 2002 · Recalled
- 2 generations backK032974 GE Logiq 5 Pro or ExpertGeneral Electric Co. · 2003
- 1 generation backK060993 GE Logiq P5 and A5General Electric Co. · 2006
- This deviceK120060 E-CUBE 9Alpinion Medical Systems Co., Ltd. · 2012
- Descendant · cites it directly · 16 of its ownK132687 E-CUBE 7Alpinion Medical Systems Co., Ltd. · 2013
- Descendant · cites it directly · 15 of its ownK150773 E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd. · 2015
- Descendant · 2 generations on · 15 of its ownK142733 E-CUBE 5Alpinion Medical Systems Co., Ltd. · 2014
- Descendant · 2 generations on · 14 of its ownK153424 E-CUBE i7Alpinion Medical Systems Co., Ltd. · 2016
- Descendant · 2 generations on · 12 of its ownK161439 E-CUBE 11Alpinion Medical Systems Co., Ltd. · 2016
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K132687E-CUBE 7Alpinion Medical Systems Co., Ltd. · 2013 · cites it directly16descendants
- K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd. · 2015 · cites it directly15descendants
- K142733E-CUBE 5Alpinion Medical Systems Co., Ltd. · 2014 · 2 generations on15descendants
- K153424E-CUBE i7Alpinion Medical Systems Co., Ltd. · 2016 · 2 generations on14descendants
- K161439E-CUBE 11Alpinion Medical Systems Co., Ltd. · 2016 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010329 | LOGIQ 500 | General Electric Co. | 2001 | — |
| −3 | K014097 | GE Logiq 5 | GE Medical Systems | 2002 | 1 |
| −2 | K032974 | GE Logiq 5 Pro or Expert | General Electric Co. | 2003 | — |
| −1 | K060993 | GE Logiq P5 and A5 | General Electric Co. | 2006 | — |
| 0 (this device) | K120060 | E-CUBE 9 | Alpinion Medical Systems Co., Ltd. | 2012 | — |
| +1 | K132687 | E-CUBE 7 | Alpinion Medical Systems Co., Ltd. | 2013 | — |
| +1 | K150773 | E-CUBE 15 Diagnostic Ultrasound System | Alpinion Medical Systems Co., Ltd. | 2015 | — |
| +2 | K142733 | E-CUBE 5 | Alpinion Medical Systems Co., Ltd. | 2014 | — |
| +2 | K153424 | E-CUBE i7 | Alpinion Medical Systems Co., Ltd. | 2016 | — |
| +2 | K161439 | E-CUBE 11 | Alpinion Medical Systems Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K060993 | GE Logiq P5 and A5Summary page 1…onic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX Predicate Device(s) K060993 LOGIC P5/AS Diagnostic Ultrasound System ALPINION MEDICAL SYSTEMS Co., Ltd.… | 2006 |
What descends from it? (23)
See all 236 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K132687 (Alpinion Medical Systems Co., Ltd., 2013) has gone furthest, with 16 descendants of its own.
- 11 other devices also cite its predicate K060993.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications: Fetal; Abdominal (renal & GYN/pelvic): Pediatric: Small Organ (breast, testes, thyroid); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(ConventiOflal); Musculo-skeletal (Superficial): Cardiac (adult & pediatric); Peripheral Vascular (PV); and Urology (including prostate).
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/K120060 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120060: E-CUBE 9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120060
Report an extraction error
Are you the manufacturer?
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