510(k) · Cleared
ClearedSonotouch Series Diagnostic Ultrasound Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chison Medical Imaging Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 2, 2012 as substantially equivalent to K102256 (Ge Medical Systems China Co., Ltd., 2010) after a 37-day review. Its family tree reaches back 10 generations to 1987. 1 later device descends from it.
- Decided
- Aug 2, 2012
- Review
- 37 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K863700 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK863700 RT2800(115V)/H4008C and RT2800(220/240V)/H4008CEGeneral Electric Co. · 1987
- 6 generations between
- 3 generations backK091164 GE Venue 40, Model 5324338Ge Medical Systems China Co., Ltd. · 2009
- 2 generations backK091374 GE Logiq I/E & Vivid E Compact UltrasoundGe Medical Systems China Co., Ltd. · 2009
- 1 generation backK102256 GE Logiq I/E & Vivid E Compact Diagnostic UltrasoundGe Medical Systems China Co., Ltd. · 2010
- This deviceK121867 Sonotouch Series Diagnostic Ultrasound SystemsChison Medical Imaging Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK170870 Site~Rite Halcyon Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd. · 2017
Show all 10 generations
- Root · 10 generations backK863700 RT2800(115V)/H4008C and RT2800(220/240V)/H4008CEGeneral Electric Co. · 1987
- 9 generations backK953752 RT55 Diagnostic Ultrasound SystemGeneral Electric Co. · 1996
- 8 generations backK012560 GE Logiq A100 MP, Model 2272413General Electric Co. · 2001
- 7 generations backK014206 LogiqbookGeneral Electric Co. · 2002 · Recalled
- 6 generations backK032477 GE Logiq BookGeneral Electric Co. · 2003
- 5 generations backK050126 GE Logiq TwinGeneral Electric Co. · 2005
- 4 generations backK072797 GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE…General Electric Co. · 2007
- 3 generations backK091164 GE Venue 40, Model 5324338Ge Medical Systems China Co., Ltd. · 2009
- 2 generations backK091374 GE Logiq I/E & Vivid E Compact UltrasoundGe Medical Systems China Co., Ltd. · 2009
- 1 generation backK102256 GE Logiq I/E & Vivid E Compact Diagnostic UltrasoundGe Medical Systems China Co., Ltd. · 2010
- This deviceK121867 Sonotouch Series Diagnostic Ultrasound SystemsChison Medical Imaging Co., Ltd. · 2012
Most influential descendants
Showing 1 of 1 · See all- K170870Site~Rite Halcyon Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K863700 | RT2800(115V)/H4008C and RT2800(220/240V)/H4008CE | General Electric Co. | 1987 | — |
| −9 | K953752 | RT55 Diagnostic Ultrasound System | General Electric Co. | 1996 | — |
| −8 | K012560 | GE Logiq A100 MP, Model 2272413 | General Electric Co. | 2001 | — |
| −7 | K014206 | Logiqbook | General Electric Co. | 2002 | 1 |
| −6 | K032477 | GE Logiq Book | General Electric Co. | 2003 | — |
| −5 | K050126 | GE Logiq Twin | General Electric Co. | 2005 | — |
| −4 | K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E… | General Electric Co. | 2007 | — |
| −3 | K091164 | GE Venue 40, Model 5324338 | Ge Medical Systems China Co., Ltd. | 2009 | — |
| −2 | K091374 | GE Logiq I/E & Vivid E Compact Ultrasound | Ge Medical Systems China Co., Ltd. | 2009 | — |
| −1 | K102256 | GE Logiq I/E & Vivid E Compact Diagnostic Ultrasound | Ge Medical Systems China Co., Ltd. | 2010 | — |
| 0 (this device) | K121867 | Sonotouch Series Diagnostic Ultrasound Systems | Chison Medical Imaging Co., Ltd. | 2012 | — |
| +1 | K170870 | Site~Rite Halcyon Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (1)
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 |
|---|---|---|---|
| * | K102256 | GE Logiq I/E & Vivid E Compact Diagnostic UltrasoundSummary page 1…echo imaging system 892.1560 90-IYO Diagnostic ultrasonic transducer 892.1570 90-ITX 2. Marketed Device: K102256,GE LOGIQ e Ultrasound System 3. Device Description: The SonoTouch Series device is a compact and extremely portab… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170870 | Site~Rite Halcyon Diagnostic Ultrasound System | 2017 | 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 25 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K170870 (Chison Medical Imaging Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K102256.
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. 2012, 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 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121867 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121867: Sonotouch Series Diagnostic Ultrasound Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121867
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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