510(k) · Cleared
ClearedSONON Ultrasound Imaging System (Model: SONON 300C)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healcerion Co., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Sep 10, 2015 as substantially equivalent to K102153 (Mobisante, Inc., 2011) and 1 other predicate after a 114-day review. Its family tree reaches back 10 generations to 1995. 33 later devices descend from it.
- Decided
- Sep 10, 2015
- Review
- 114 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K935595 (1995). 96 ancestors in all, the oldest K850478 (1985). 33 later devices descend from it, 5 citing it directly.
- Root · 10 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 6 generations between
- 3 generations backK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- 1 generation backK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- This deviceK151339 SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015
- Descendant · cites it directly · 28 of its ownK163138 Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016
- Descendant · 2 generations on · 22 of its ownK172385 Clarius Ultrasound SystemClarius Mobile Health Corp. · 2017
- Descendant · 3 generations on · 11 of its ownK180799 Clarius Ultrasound ScannerClarius Mobile Health Corp. · 2018
- Descendant · 4 generations on · 10 of its ownK192107 Clarius Ultrasound ScannerClarius Mobile Health Corp. · 2019
- Descendant · 3 generations on · 9 of its ownK191235 Leltek Ultrasound Imaging SystemLeltek, Inc. · 2020
Show all 10 generations
- Root · 10 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 8 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 7 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 6 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 5 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 4 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 3 generations backK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- 1 generation backK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- This deviceK151339 SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K163138Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016 · cites it directly28descendants
- K172385Clarius Ultrasound SystemClarius Mobile Health Corp. · 2017 · 2 generations on22descendants
- K180799Clarius Ultrasound ScannerClarius Mobile Health Corp. · 2018 · 3 generations on11descendants
- K192107Clarius Ultrasound ScannerClarius Mobile Health Corp. · 2019 · 4 generations on10descendants
- K191235Leltek Ultrasound Imaging SystemLeltek, Inc. · 2020 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −9 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −8 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −7 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −6 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −5 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −4 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −3 | K063761 | Acuson P10 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −2 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
| −1 | K102153 | Mobius Ultrasound Imaging System | Mobisante, Inc. | 2011 | — |
| 0 (this device) | K151339 | SONON Ultrasound Imaging System (Model: SONON 300C) | Healcerion Co., Ltd. | 2015 | — |
| +1 | K163138 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2016 | — |
| +2 | K172385 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2017 | — |
| +3 | K180799 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2018 | — |
| +4 | K192107 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2019 | — |
| +3 | K191235 | Leltek Ultrasound Imaging System | Leltek, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 11 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K102153 | Mobius Ultrasound Imaging SystemSummary page 5…evices Device Name 510(k) Number MobiUS Ultrasound Imaging System (Mobisante, Inc.) K102153 Penrith Elettra Diagnostic Ultrasound System (Penrith Corp.) K100598 Healcerion is not aware of any design-rela… | 2011 |
| * | K100598 | Penrith Elettra Ultrasound SystemSummary page 5…510(k) Number MobiUS Ultrasound Imaging System (Mobisante, Inc.) K102153 Penrith Elettra Diagnostic Ultrasound System (Penrith Corp.) K100598 Healcerion is not aware of any design-related recalls regarding the predicate devices. No reference devices were used in… | 2010 |
What descends from it? (33)
See all 335 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163138 | Clarius Ultrasound System | 2016 | 28 |
| K172750 | Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) | 2018 | 4 |
| K170085 | SONON Ultrasound Imaging System, Model: 300L | 2017 | 4 |
| K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB… | 2022 | 0 |
| K211665 | SONON Ultrasound Imaging System, Model: SONON300C | 2022 | 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 20 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 96 ancestors have a recall of any class.
- Of its descendants, K163138 (Clarius Mobile Health Corp., 2016) has gone furthest, with 28 descendants of its own.
- 3 other devices also cite its predicate K102153.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The SONON Ultrasound Imaging System (Model: SONON 300C) is intended for diagnostic ultrasound
echo imaging, measurement, and analysis of the human body for general clinical applications including
obstetrics (OB), gynecology (GY) and general (abdominal) imaging.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151339: SONON Ultrasound Imaging System (Model: SONON 300C).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151339
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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