510(k) · Cleared
ClearedSonoace R7 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 Dec 27, 2013 as substantially equivalent to K112646 (Samsung Medison Co., Ltd., 2011) and 6 other predicates after a 43-day review. Its family tree reaches back 17 generations to 1993. 98 later devices descend from it.
- Decided
- Dec 27, 2013
- Review
- 43 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 17 generations to K924432 (1993). 43 ancestors in all. 98 later devices descend from it, 3 citing it directly.
- Root · 17 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 13 generations between
- 3 generations backK112339 Accuvix A30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- 2 generations backK122583 Ugeo G60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2012
- 1 generation backK130803 Ugeo H70C Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- This deviceK133505 Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- Descendant · cites it directly · 97 of its ownK150478 A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- Descendant · 2 generations on · 96 of its ownK151663 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- Descendant · 2 generations on · 90 of its ownK152962 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- Descendant · 2 generations on · 89 of its ownK153529 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · Recalled
- Descendant · 3 generations on · 65 of its ownK153408 HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
Show all 17 generations
- Root · 17 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 16 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 15 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 14 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 13 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 12 generations backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- 11 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 10 generations backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- 9 generations backK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- 8 generations backK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- 7 generations backK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 6 generations backK093849 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 5 generations backK101455 Eko 7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 4 generations backK103397 Accuvix XG Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011
- 3 generations backK112339 Accuvix A30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- 2 generations backK122583 Ugeo G60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2012
- 1 generation backK130803 Ugeo H70C Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- This deviceK133505 Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
Showing 5 of 98 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 98 · See all- K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · cites it directly97descendants
- K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · 2 generations on96descendants
- K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · 2 generations on90descendants
- K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · 2 generations on89descendants
- K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · 3 generations on65descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −16 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −15 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −14 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −13 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −12 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| −11 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| −10 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| −9 | K070813 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2007 | — |
| −8 | K080800 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| −7 | K092159 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −6 | K093849 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −5 | K101455 | Eko 7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −4 | K103397 | Accuvix XG Diagnostic Ultrasound System | Medison Co., Ltd. | 2011 | — |
| −3 | K112339 | Accuvix A30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| −2 | K122583 | Ugeo G60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2012 | — |
| −1 | K130803 | Ugeo H70C Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| 0 (this device) | K133505 | Sonoace R7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| +1 | K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| +2 | K151663 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| +2 | K152962 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| +2 | K153529 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | 1 |
| +3 | K153408 | HM70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 4 | 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? (7)
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 |
|---|---|---|---|
| * | K112646 | Sonoace R7 Diagnostic Ultrasound SystemSummary page 10…P P P P P Notw I Note 2,5,6,7,2,9, 12 Vessel Other (spec.) N=new indication: N- previously cleared by FDA K 112646; E= added under Appendix E Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: R-M. B+PW, 13,C,… | 2011 |
| * | K130803 | Ugeo H70C Diagnostic Ultrasound SystemSummary page 1…f the predicate or legally marketed device: - SONOACE R7 Diagnostic Ultrasound System(KI 12646) - UGEO HM70A Diagnostic Ultrasound System (K 130803) - ACCUVIX A30 Diagnostic Ultrasound System(KI 12339) - EKO 7 Diagnostic Ultrasound System (K101455… | 2013 |
| * | K112339 | Accuvix A30 Diagnostic Ultrasound SystemSummary page 2…o safety effectiveness, and functionality to the SONOACE R7 Diagnostic Ultrasound System (KI112646) and ACCUVIX A30 Diagnostic Ultrasound System (K 112339). It is substantially equivalent with respect to safety, effectiveness, and functionality to the Bodymarker of… | 2011 |
| * | K101455 | Eko 7 Diagnostic Ultrasound SystemSummary page 1…EO HM70A Diagnostic Ultrasound System (K 130803) - ACCUVIX A30 Diagnostic Ultrasound System(KI 12339) - EKO 7 Diagnostic Ultrasound System (K101455) - UGEO H60 Diagnostic Ultrasound System (K 122583) - UOEO PT60A Diagnostic Ultrasound System (K]32… | 2010 |
| * | K122583 | Ugeo G60 Diagnostic Ultrasound SystemSummary page 1…ACCUVIX A30 Diagnostic Ultrasound System(KI 12339) - EKO 7 Diagnostic Ultrasound System (K101455) - UGEO H60 Diagnostic Ultrasound System (K 122583) - UOEO PT60A Diagnostic Ultrasound System (K]32228) - MySono U6 Diagnostic Ultrasound System (KI 1… | 2012 |
| * | K132228 | Ugeo PT60A Diagnostic Ultrasound SystemSummary page 31…P P p P Note | Note 4, 7 Tians-esophageal (Catdiac) Other rgpec,} Peripherat Petipheral vessel Vessel Other (spec) . N= new indication; P= previousty cleared byFDA K132228: E= added under Appendix E Additional Comments: Color Dappler includes Power {Amplitude) Dopplet Note 1 BN, BePW, 102, 150000 13… | 2013 |
| * | K113381 | Mysono U6 Diagnostic Ultrasound SystemSummary page 25…Pediantic Trans-csophageal (Candiac) Other (spec) Peripheral Vessel Pepipheral vessel Note 1 Notes 8,9 Other {spec.) N new mdication: P prevaously cleared byFDA K 113381, E=added under Appendix 2 Addirional Comments: Color Doppler inchudes Powcet (Amplitude) Doppler Note 1T H M, R PW, B+, R+PD, B-D… | 2011 |
What descends from it? (98)
See all 983 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 20 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 2 of the 43 ancestors have a recall of any class.
- Of its descendants, K150478 (Samsung Medison Co., Ltd., 2015) has gone furthest, with 97 descendants of its own.
- 4 other devices also cite its predicate K112646.
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. 2013, 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 SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid flow analysis of the human body.
The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trns-rectal, Trams-vaginal. Muscular-Skeletal (Convenitional, Superficial), 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/K133505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133505: Sonoace R7 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/K133505
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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