510(k) · Cleared
ClearedRS80A 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 Aug 12, 2015 as substantially equivalent to K141620 (Samsung Medison Co., Ltd., 2014) and 9 other predicates after a 54-day review. Its family tree reaches back 21 generations to 1993. 96 later devices descend from it.
- Decided
- Aug 12, 2015
- Review
- 54 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 21 generations to K924432 (1993). 200 ancestors in all, the oldest K863700 (1987). 96 later devices descend from it, 7 citing it directly.
- Root · 21 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 17 generations between
- 3 generations backK141620 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- 2 generations backK143089 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- 1 generation backK150478 A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- This deviceK151663 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- Descendant · cites it directly · 90 of its ownK152962 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- Descendant · cites it directly · 89 of its ownK153529 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · Recalled
- Descendant · cites it directly · 65 of its ownK153408 HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- Descendant · cites it directly · 64 of its ownK162094 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
- Descendant · cites it directly · 59 of its ownK153539 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
Show all 21 generations
- Root · 21 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 20 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 19 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 18 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 17 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 16 generations backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- 15 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 14 generations backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- 13 generations backK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- 12 generations backK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- 11 generations backK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 10 generations backK093849 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 9 generations backK101455 Eko 7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 8 generations backK103397 Accuvix XG Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011
- 7 generations backK112339 Accuvix A30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- 6 generations backK122583 Ugeo G60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2012
- 5 generations backK130803 Ugeo H70C Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- 4 generations backK133329 Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- 3 generations backK141620 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- 2 generations backK143089 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- 1 generation backK150478 A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- This deviceK151663 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
Showing 5 of 96 descendants. See all descendants
Descendants cleared per year
2015high 11 (2018) · low 2 (2015)2026
Most influential descendants
Showing 5 of 96 · See all- K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · cites it directly90descendants
- K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · cites it directly89descendants
- K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · cites it directly65descendants
- K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · cites it directly64descendants
- K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · cites it directly59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −20 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −19 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −18 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −17 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −16 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| −15 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| −14 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| −13 | K070813 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2007 | — |
| −12 | K080800 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| −11 | K092159 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −10 | K093849 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −9 | K101455 | Eko 7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −8 | K103397 | Accuvix XG Diagnostic Ultrasound System | Medison Co., Ltd. | 2011 | — |
| −7 | K112339 | Accuvix A30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| −6 | K122583 | Ugeo G60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2012 | — |
| −5 | K130803 | Ugeo H70C Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| −4 | K133329 | Ugeo WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| −3 | K141620 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| −2 | K143089 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| −1 | K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| 0 (this device) | K151663 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| +1 | K152962 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| +1 | K153529 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | 1 |
| +1 | K153408 | HM70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| +1 | K162094 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
| +1 | K153539 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
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 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 7 | 0 |
| 1998 | 4 | 0 |
| 1999 | 9 | 0 |
| 2000 | 8 | 0 |
| 2001 | 10 | 0 |
| 2002 | 13 | 0 |
| 2003 | 15 | 0 |
| 2004 | 18 | 0 |
| 2005 | 14 | 0 |
| 2006 | 9 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 6 | 0 |
| 2010 | 9 | 0 |
| 2011 | 10 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 6 | 0 |
| 2017 | 10 | 0 |
| 2018 | 11 | 0 |
| 2019 | 11 | 0 |
| 2020 | 7 | 0 |
| 2021 | 11 | 0 |
| 2022 | 11 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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? (10)
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 |
|---|---|---|---|
| * | K141620 | RS80A Diagnostic Ultrasound SystemSummary page 4…P P P Note 1 Note 2, 5, 6, 7, 8, 9, 11, 14 Vessel Other (spec.) N= new indication; P= previously cleared by FDA K141620; E= added under Appendix E Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW,… | 2014 |
| * | K150478 | A35 Diagnostic Ultrasound SystemSummary page 19…P P P P Note 1 Note 2, 5, 6, 7, 9, 11 Vessel Other (spec.) N= new indication; P= previously cleared by FDA K150478; E= added under Appendix E Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW,… | 2015 |
| * | K143089 | WS80A Diagnostic Ultrasound SystemSummary page 18…rdiac) Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.) N= new indication; P= previously cleared by FDA K143089 ; E= added under Appendix E Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW… | 2014 |
| * | K130803 | Ugeo H70C Diagnostic Ultrasound SystemSummary page 22…rdiac) Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.) N= new indication; P= previously cleared by FDA K130803 (P3-8); E= added under Appendix E Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M… | 2013 |
| * | K142466 | UGEO PT60A Diagnostic Ultrasound SystemSummary page 23…rdiac) Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.) N= new indication; P= previously cleared by FDA K142466 (P4-12); E= added under Appendix E Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+… | 2014 |
| * | K142160 | Logiq E9 Diagnostic Ultrasound SystemSummary page 27…- HM70A Diagnostic Ultrasound System (K130803) - PT60A Diagnostic Ultrasound System (K142466) - LOGIQ E9 Diagnostic Ultrasound System (K142160) - Aixplorer Diagnostic Ultrasound System (K132274) - S2000/S3000 Diagnostic Ultrasound System (K131164… | 2014 |
| * | K132274 | AixplorerSummary page 27…- PT60A Diagnostic Ultrasound System (K142466) - LOGIQ E9 Diagnostic Ultrasound System (K142160) - Aixplorer Diagnostic Ultrasound System (K132274) - S2000/S3000 Diagnostic Ultrasound System (K131164/K130881) - QLAB (K021966) 510(k) Summary / Stat… | 2013 |
| * | K131164 | AcusonSummary page 27…LOGIQ E9 Diagnostic Ultrasound System (K142160) - Aixplorer Diagnostic Ultrasound System (K132274) - S2000/S3000 Diagnostic Ultrasound System (K131164/K130881) - QLAB (K021966) 510(k) Summary / Statement Certification… | 2013 |
| * | K130881 | Acuson S2000 and S3000Summary page 27…9 Diagnostic Ultrasound System (K142160) - Aixplorer Diagnostic Ultrasound System (K132274) - S2000/S3000 Diagnostic Ultrasound System (K131164/K130881) - QLAB (K021966) 510(k) Summary / Statement Certification AT… | 2013 |
| * | K021966 | Q Lab SoftwareSummary page 27…(K142160) - Aixplorer Diagnostic Ultrasound System (K132274) - S2000/S3000 Diagnostic Ultrasound System (K131164/K130881) - QLAB (K021966) 510(k) Summary / Statement Certification ATTACHEMENT 1 5… | 2002 |
What descends from it? (96)
See all 967 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152962 | HS70A Diagnostic Ultrasound System | 2015 | 90 |
| K153529 | WS80A Diagnostic Ultrasound System | 2016 | 89 |
| K153408 | HM70A Diagnostic Ultrasound System | 2015 | 65 |
| K162094 | RS80A Diagnostic Ultrasound System | 2016 | 64 |
| K153539 | RS80A Diagnostic Ultrasound System | 2016 | 59 |
| K153424 | E-CUBE i7 | 2016 | 14 |
| K161955 | 5D Viewer | 2016 | 3 |
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 22 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 45 of the 200 ancestors have a recall of any class.
- Of its descendants, K152962 (Samsung Medison Co., Ltd., 2015) has gone furthest, with 90 descendants of its own.
- 3 other devices also cite its predicate K141620.
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. 2015, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2007high 64 (2017) · low 13 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
2007high 124 (2025) · low 18 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
2007high 16 (2007) · low 0 (2017)2026
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
2007high 610 (2025) · low 2 (2008)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 RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid
analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic,
Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult,
Cardiac Pediatric and Peripheral vessel.
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/K151663 · printed Nov 3, 2026
Cite this page
510(k) Report. “K151663: RS80A Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K151663
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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