510(k) · Cleared
ClearedV8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Samsung Medison Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jul 28, 2026 as substantially equivalent to K250999 (Samsung Medison Co., Ltd., 2025) after an 89-day review. Its family tree reaches back 38 generations to 1993. 1 later device descends from it.
- Decided
- Jul 28, 2026
- Review
- 89 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 38 generations to K924432 (1993). 304 ancestors in all, the oldest K863700 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 38 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 34 generations between
- 3 generations backK240631 V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2024
- 2 generations backK243702 V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System…Samsung Medison Co., Ltd. · 2025
- 1 generation backK250999 V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System…Samsung Medison Co., Ltd. · 2025
- This deviceK261412 V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic…Samsung Medison Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK263182 EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound…Samsung Medison Co., Ltd. · 2026
Show all 38 generations
- Root · 38 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 37 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 36 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 35 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 34 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 33 generations backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- 32 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 31 generations backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- 30 generations backK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- 29 generations backK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- 28 generations backK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 27 generations backK093849 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 26 generations backK101455 Eko 7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 25 generations backK103397 Accuvix XG Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011
- 24 generations backK112339 Accuvix A30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- 23 generations backK122583 Ugeo G60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2012
- 22 generations backK130803 Ugeo H70C Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- 21 generations backK133329 Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- 20 generations backK141620 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- 19 generations backK143089 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- 18 generations backK150478 A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- 17 generations backK151663 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- 16 generations backK152962 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- 15 generations backK153529 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · Recalled
- 14 generations backK162094 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
- 13 generations backK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 12 generations backK170493 HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 11 generations backK172129 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 10 generations backK180409 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
- 9 generations backK181336 HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
- 8 generations backK192903 RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2020
- 7 generations backK211945 V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2021
- 6 generations backK220975 V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2022
- 5 generations backK223387 V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2023
- 4 generations backK231772 V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound…Samsung Medison Co., Ltd. · 2023
- 3 generations backK240631 V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2024
- 2 generations backK243702 V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System…Samsung Medison Co., Ltd. · 2025
- 1 generation backK250999 V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System…Samsung Medison Co., Ltd. · 2025
- This deviceK261412 V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic…Samsung Medison Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −38 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −37 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −36 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −35 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −34 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −33 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| −32 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| −31 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| −30 | K070813 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2007 | — |
| −29 | K080800 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| −28 | K092159 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −27 | K093849 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −26 | K101455 | Eko 7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −25 | K103397 | Accuvix XG Diagnostic Ultrasound System | Medison Co., Ltd. | 2011 | — |
| −24 | K112339 | Accuvix A30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| −23 | K122583 | Ugeo G60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2012 | — |
| −22 | K130803 | Ugeo H70C Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| −21 | K133329 | Ugeo WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| −20 | K141620 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| −19 | K143089 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| −18 | K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| −17 | K151663 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| −16 | K152962 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| −15 | K153529 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | 1 |
| −14 | K162094 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
| −13 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| −12 | K170493 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| −11 | K172129 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| −10 | K180409 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
| −9 | K181336 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
| −8 | K192903 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020 | — |
| −7 | K211945 | V8 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021 | — |
| −6 | K220975 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2022 | — |
| −5 | K223387 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2023 | — |
| −4 | K231772 | V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6… | Samsung Medison Co., Ltd. | 2023 | — |
| −3 | K240631 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2024 | — |
| −2 | K243702 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7… | Samsung Medison Co., Ltd. | 2025 | — |
| −1 | K250999 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7… | Samsung Medison Co., Ltd. | 2025 | — |
| 0 (this device) | K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound… | Samsung Medison Co., Ltd. | 2026 | — |
| +1 | K263182 | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System… | Samsung Medison Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 10 | 0 |
| 1998 | 4 | 0 |
| 1999 | 10 | 0 |
| 2000 | 9 | 0 |
| 2001 | 15 | 0 |
| 2002 | 14 | 0 |
| 2003 | 23 | 0 |
| 2004 | 23 | 0 |
| 2005 | 15 | 0 |
| 2006 | 12 | 0 |
| 2007 | 10 | 0 |
| 2008 | 9 | 0 |
| 2009 | 8 | 0 |
| 2010 | 16 | 0 |
| 2011 | 15 | 0 |
| 2012 | 14 | 0 |
| 2013 | 14 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K250999 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Summary page 6…2050 6. Predicate / Reference Device - Predicate device • V8/cV8, V7/cV7, V6/cV6, V5/cV5, V4/cV4 Diagnostic Ultrasound System (K250999) - Reference Device • HERA Z20, HERA Z20e, HERA Z20s, R20, HERA Z30, R30 Diagnostic Ultrasou… | 2025 |
| † | K252018 | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s… | 2026 |
| † | K240516 | RS85 Diagnostic Ultrasound System | 2024 |
| † | K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10… | 2026 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K263182 | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10… | 2026 | 0 |
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 33 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 72 of the 304 ancestors have a recall of any class.
- Of its descendants, K263182 (Samsung Medison Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
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. 2026, 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?
For V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System, VT7IXVTIXH7/H7/cVTINT ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System, V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE: The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small…
Read the full statement (316 words)
For V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System, VT7IXVTIXH7/H7/cVTINT ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System, V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE:
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Ophthalmic, Trans-esophageal (Cardiac) and Peripheral vessel.
It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.
Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, MV-Flow mode, Combined modes, Multi-image mode(Dual, Quad), 3D/4D mode.
For V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System, V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System:
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac), Peripheral vessel and Dermatology.
It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.
Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, MV-Flow Mode, Combined modes, Multi-image mode(Dual, Quad), 3D/4D mode.
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/K261412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261412: V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261412
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026