510(k) · Cleared
ClearedSmartUs EXT-1M/3M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Telemed · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 10, 2017 as substantially equivalent to K113184 (Telemed, 2012) and 1 other predicate after a 275-day review. Its family tree reaches back 15 generations to 1993. 2 later devices descend from it.
- Decided
- Aug 10, 2017
- Review
- 275 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K924432 (1993). 27 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 11 generations between
- 3 generations backK102065 Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 2 generations backK112646 Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- 1 generation backK113184 Logicscan 64 Logicscan 128Telemed · 2012
- This deviceK163121 SmartUs EXT-1M/3MTelemed · 2017
- Descendant · cites it directly · 0 of its ownK211248 ArtUsTelemed · 2022
- Descendant · cites it directly · 0 of its ownK181124 Acessa ProVu SystemAcessa Health, Inc. · 2018
Show all 15 generations
- Root · 15 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 14 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 13 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 12 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 11 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 10 generations backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- 9 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 8 generations backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- 7 generations backK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- 6 generations backK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- 5 generations backK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 4 generations backK093714 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 3 generations backK102065 Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 2 generations backK112646 Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- 1 generation backK113184 Logicscan 64 Logicscan 128Telemed · 2012
- This deviceK163121 SmartUs EXT-1M/3MTelemed · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −14 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −13 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −12 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −11 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −10 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| −9 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| −8 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| −7 | K070813 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2007 | — |
| −6 | K080800 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| −5 | K092159 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −4 | K093714 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −3 | K102065 | Sonoace R7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −2 | K112646 | Sonoace R7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| −1 | K113184 | Logicscan 64 Logicscan 128 | Telemed | 2012 | — |
| 0 (this device) | K163121 | SmartUs EXT-1M/3M | Telemed | 2017 | — |
| +1 | K211248 | ArtUs | Telemed | 2022 | — |
| +1 | K181124 | Acessa ProVu System | Acessa Health, Inc. | 2018 | — |
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 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K113184 | Logicscan 64 Logicscan 128Summary page 8…Propietary Name SmartUs EXT-1M/3M Class Regulatory Class II Predicate Device TELEMED LS128 K113184 SAMSUNG MEDISON SONOACE R7 K112646 3. Performance Standards The SmartUs Smar… | 2012 |
| * | K112646 | Sonoace R7 Diagnostic Ultrasound SystemSummary page 8…egulatory Class II Predicate Device TELEMED LS128 K113184 SAMSUNG MEDISON SONOACE R7 K112646 3. Performance Standards The SmartUs SmartUs EXT-1M/3M has been designed to meet the following: Safety and EMC Requiremen… | 2011 |
What descends from it? (2)
2 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 24 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K211248 (Telemed, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K113184.
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. 2017, 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?
SmartUs EXT-1M/3M ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), adult cefalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel (B and M-mode, combined modes imaging, including imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at thebedside systems, for navigatedmedical application, in operating rooms/critical care units.
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/K163121 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163121: SmartUs EXT-1M/3M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163121
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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