510(k) · Cleared
ClearedX-CUBE i8, X-CUBE i9
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 Jan 28, 2022 as substantially equivalent to K182594 (Alpinion Medical Systems Co., Ltd., 2019) after an 86-day review. Its family tree reaches back 28 generations to 1993. 6 of the 330 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 28, 2022
- Review
- 86 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 28 generations to K924432 (1993). 329 ancestors in all, the oldest K863700 (1987). No later device cites it as a predicate yet. 6 of the 330 devices in this family, counting this one, have a Class I recall.
- Root · 28 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 24 generations between
- 3 generations backK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 2 generations backK172732 E-CUBE 8Alpinion Medical Systems Co., Ltd. · 2017
- 1 generation backK182594 E-CUBE i7Alpinion Medical Systems Co., Ltd. · 2019
- This deviceK213523 X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd. · 2022
Show all 28 generations
- Root · 28 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 27 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 26 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 25 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 24 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 23 generations backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- 22 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 21 generations backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- 20 generations backK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- 19 generations backK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- 18 generations backK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 17 generations backK093849 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 16 generations backK101455 Eko 7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 15 generations backK103397 Accuvix XG Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011
- 14 generations backK112339 Accuvix A30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- 13 generations backK122583 Ugeo G60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2012
- 12 generations backK130803 Ugeo H70C Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- 11 generations backK133329 Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- 10 generations backK141620 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- 9 generations backK143089 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- 8 generations backK150478 A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- 7 generations backK151663 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- 6 generations backK152962 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- 5 generations backK153529 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · Recalled
- 4 generations backK162094 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
- 3 generations backK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 2 generations backK172732 E-CUBE 8Alpinion Medical Systems Co., Ltd. · 2017
- 1 generation backK182594 E-CUBE i7Alpinion Medical Systems Co., Ltd. · 2019
- This deviceK213523 X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd. · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −28 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −27 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −26 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −25 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −24 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −23 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| −22 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| −21 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| −20 | K070813 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2007 | — |
| −19 | K080800 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| −18 | K092159 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −17 | K093849 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −16 | K101455 | Eko 7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −15 | K103397 | Accuvix XG Diagnostic Ultrasound System | Medison Co., Ltd. | 2011 | — |
| −14 | K112339 | Accuvix A30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| −13 | K122583 | Ugeo G60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2012 | — |
| −12 | K130803 | Ugeo H70C Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| −11 | K133329 | Ugeo WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| −10 | K141620 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| −9 | K143089 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| −8 | K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| −7 | K151663 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| −6 | K152962 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| −5 | K153529 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | 1 |
| −4 | K162094 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
| −3 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| −2 | K172732 | E-CUBE 8 | Alpinion Medical Systems Co., Ltd. | 2017 | — |
| −1 | K182594 | E-CUBE i7 | Alpinion Medical Systems Co., Ltd. | 2019 | — |
| 0 (this device) | K213523 | X-CUBE i8, X-CUBE i9 | Alpinion Medical Systems Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 8 | 0 |
| 1995 | 8 | 0 |
| 1996 | 6 | 1 |
| 1997 | 12 | 0 |
| 1998 | 13 | 3 |
| 1999 | 14 | 0 |
| 2000 | 15 | 1 |
| 2001 | 22 | 0 |
| 2002 | 20 | 0 |
| 2003 | 25 | 0 |
| 2004 | 24 | 1 |
| 2005 | 17 | 0 |
| 2006 | 11 | 0 |
| 2007 | 9 | 0 |
| 2008 | 8 | 0 |
| 2009 | 7 | 0 |
| 2010 | 12 | 0 |
| 2011 | 14 | 0 |
| 2012 | 15 | 0 |
| 2013 | 16 | 0 |
| 2014 | 10 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 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.
6 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 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 |
|---|---|---|---|
| * | K182594 | E-CUBE i7Summary page 4…ulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX Primary K182594 E-CUBE i7 Ultrasonic Pulsed Doppler Imaging System Predicate Device Referen… | 2019 |
| † | K211300 | X-CUBE 90 | 2021 |
| † | K181277 | E-CUBE 12 | 2018 |
| † | K150773 | E-CUBE 15 Diagnostic Ultrasound System | 2015 |
| † | K181617 | E-CUBE 8 | 2018 |
| † | K161439 | E-CUBE 11 | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 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.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 6 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 6 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 6 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- 83 of the 329 ancestors have a recall of any class; 6 have a Class I recall.
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. 2022, 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 X-CUBE i8, X-CUBE 19 diagnostic ultrasound systems are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional)…
Read the full statement (129 words)
The X-CUBE i8, X-CUBE 19 diagnostic ultrasound systems are intended for use by, or by the order of, and under the
supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical
applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal
Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial);
Cardiac(adult& pediatric); Trans-esoph. (Cardiac); Peripheral Vessel(PV); and Urology(including prostate).
And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color
Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode;
Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode.
The X-CUBE 18, X-CUBE 19 are intended to be used in a hospital or medical clinic.
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/K213523 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213523: X-CUBE i8, X-CUBE i9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213523
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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