510(k) · Cleared
ClearedChison Diagnostic Ultrasound System, Convex Probe, Lincar Probe, Phased 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 Aug 1, 2013 as substantially equivalent to K102256 (Ge Medical Systems China Co., Ltd., 2010) after an 86-day review. Its family tree reaches back 10 generations to 1987. 1 later device descends from it.
- Decided
- Aug 1, 2013
- Review
- 86 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 deviceK131305 Chison Diagnostic Ultrasound System, Convex Probe, Lincar Probe…Chison Medical Imaging Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK231659 MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert…Medisono · 2024
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 deviceK131305 Chison Diagnostic Ultrasound System, Convex Probe, Lincar Probe…Chison Medical Imaging Co., Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono · 2024 · 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) | K131305 | Chison Diagnostic Ultrasound System, Convex Probe, Lincar Probe, Phased Probe | Chison Medical Imaging Co., Ltd. | 2013 | — |
| +1 | K231659 | MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital… | Medisono | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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…lsed echo imaging system 892.1560 90-IYO Diagnostic ultrasonic transducer 892.1570 90-ITX 2. Marketed Device: K102256,GE LOGIO e Ultrasound System 3. Device Description: The ECO Series Diagnostic Ultrasound Systems is a very compact and por… | 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 |
|---|---|---|---|
| K231659 | MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color… | 2024 | 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 26 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, K231659 (Medisono, 2024) 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. 2013, 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/K131305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131305: Chison Diagnostic Ultrasound System, Convex Probe, Lincar Probe, Phased Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131305
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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