510(k) · Cleared
ClearedSonoace Pico Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medison Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on May 16, 2006 as substantially equivalent to K013627 (Medison America, Inc., 2001) and 1 other predicate after a 14-day review. Its family tree reaches back 7 generations to 1993. 114 later devices descend from it.
- Decided
- May 16, 2006
- Review
- 14 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K924432 (1993). 14 ancestors in all. 114 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 6 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 5 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 4 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 3 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 2 generations backK031552 Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · Recalled
- 1 generation backK043455 SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004
- This deviceK061213 Sonoace Pico Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- Descendant · cites it directly · 111 of its ownK100186 Mysono U5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- Descendant · 2 generations on · 110 of its ownK102065 Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- Descendant · 3 generations on · 108 of its ownK112646 Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- Descendant · cites it directly · 104 of its ownK101829 The Sonoace R3 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- Descendant · 2 generations on · 103 of its ownK103722 The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011
Showing 5 of 114 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 114 · See all- K100186Mysono U5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010 · cites it directly111descendants
- K102065Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010 · 2 generations on110descendants
- K112646Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011 · 3 generations on108descendants
- K101829The Sonoace R3 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010 · cites it directly104descendants
- K103722The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011 · 2 generations on103descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −6 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −5 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −4 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −3 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −2 | K031552 | Mycolor 202 Diagnostic Ultrasound System and Transducers | Medison America, Inc. | 2003 | 5 |
| −1 | K043455 | SA8000 SE Diagnostic Ultrasound System | Medison Co., Ltd. | 2004 | — |
| 0 (this device) | K061213 | Sonoace Pico Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| +1 | K100186 | Mysono U5 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| +2 | K102065 | Sonoace R7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| +3 | K112646 | Sonoace R7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| +1 | K101829 | The Sonoace R3 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| +2 | K103722 | The Sonoace R5 Diagnostic Ultrasound System | Medison Co., Ltd. | 2011 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 11 | 0 |
| 2018 | 13 | 0 |
| 2019 | 11 | 0 |
| 2020 | 7 | 0 |
| 2021 | 11 | 0 |
| 2022 | 12 | 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? (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 |
|---|---|---|---|
| * | K013627 | Sonoace SA-8000 Diagnostic Ultrasound SystemSummary page 1…Diagnostic Ultrasound Transducer 892.1570 90-ITX 3. Identification of the predicate or legally marketed device: K013627, 11/16/2001, SA8000 Ultrasound system K043455, 12/21/2004, SA8000 SE Ultrasound system 4. Device Description:… | 2001 |
| * | K043455 | SA8000 SE Diagnostic Ultrasound SystemSummary page 1…90-ITX 3. Identification of the predicate or legally marketed device: K013627, 11/16/2001, SA8000 Ultrasound system K043455, 12/21/2004, SA8000 SE Ultrasound system 4. Device Description: The SONOACE PICO is a general purpose, mobile, softwar… | 2004 |
What descends from it? (114)
See all 1143 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 13 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K100186 (Medison Co., Ltd., 2010) has gone furthest, with 111 descendants of its own.
- 5 other devices also cite its predicate K013627.
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.
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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061213 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061213: Sonoace Pico Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061213
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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