510(k) · Cleared
ClearedChison Diagnostic Ultrasound System, Convex Probe, Linear Probe, Phased and Convex Probe, Pencil and Convex Probe
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 Jun 2, 2014 as substantially equivalent to K101236 (GE Healthcare, 2011) and 1 other predicate after a 110-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jun 2, 2014
- Review
- 110 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K003525 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK003525 Voluson 730 Diagnostic Ultrasound SystemMedison America, Inc. · 2000
- 5 generations backK032620 GE Voluson 730 Pro/Expert BT03 Ultrasound SystemGeneral Electric Co. · 2003
- 4 generations backK041688 GE Voluson 730 Pro/Expert Untrasound BT04General Electric Co. · 2004 · Recalled
- 3 generations backK061682 GE Voluson E8 Ultrasound SystemGeneral Electric Co. · 2006 · Recalled
- 2 generations backK101236 Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model…GE Healthcare · 2011
- 1 generation backK120801 Chison Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd. · 2012
- This deviceK140364 Chison Diagnostic Ultrasound System, Convex Probe, Linear Probe…Chison Medical Imaging Co., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003525 | Voluson 730 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | — |
| −5 | K032620 | GE Voluson 730 Pro/Expert BT03 Ultrasound System | General Electric Co. | 2003 | — |
| −4 | K041688 | GE Voluson 730 Pro/Expert Untrasound BT04 | General Electric Co. | 2004 | 1 |
| −3 | K061682 | GE Voluson E8 Ultrasound System | General Electric Co. | 2006 | 3 |
| −2 | K101236 | Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/… | GE Healthcare | 2011 | — |
| −1 | K120801 | Chison Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | 2012 | — |
| 0 (this device) | K140364 | Chison Diagnostic Ultrasound System, Convex Probe, Linear Probe, Phased and… | Chison Medical Imaging Co., Ltd. | 2014 | — |
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 |
|---|---|---|---|
| * | K101236 | Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BMSummary page 1…tem 892.1560 90-IYG Diagnostic ultrasonic transducer 892.1570 90-ITX 4. Legally Marketed Predicate Device: K1 01236, GE Voluson E6/E8 /E8 Expert Diagnostic Ultrasound System K120801 CHISON iVis6OEXPERT, Q6/Q8, i7 Diagnostic Ultrasound Systems… | 2011 |
| * | K120801 | Chison Diagnostic Ultrasound SystemSummary page 1…transducer 892.1570 90-ITX 4. Legally Marketed Predicate Device: K1 01236, GE Voluson E6/E8 /E8 Expert Diagnostic Ultrasound System K120801 CHISON iVis6OEXPERT, Q6/Q8, i7 Diagnostic Ultrasound Systems 5. Device Description: 510(k) Summary… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 7 other devices also cite its predicate K101236.
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. 2014, 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 instument 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, Transvaginal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140364: Chison Diagnostic Ultrasound System, Convex Probe, Linear Probe, Phased and Convex Probe, Pencil and Convex Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140364
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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