510(k) · Cleared
ClearedChison Digital Color Doppler Ultrasound System, Convex Probe, Linear Probe, Phased Array Probe, Transvaginal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chison Medical Imaging Co., Ltd. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Sep 2, 2009 as substantially equivalent to K052042 (Sonoscape Company Limited, 2005) after a 71-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Sep 2, 2009
- Review
- 71 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K933202 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK933202 Venus Diagnostic Ultrasound SystemGE Medical Systems · 1994
- 4 generations backK970901 GE Logiq 500 Diagnostic Ultrasound SystemGE Medical Systems · 1997
- 3 generations backK991611 GE Logiq 500General Electric Co. · 1999
- 2 generations backK042369 Sonoscape Ultrasound System Ssi-1000/Ssi-5000Sonoscape Company Limited · 2004
- 1 generation backK052042 Sonoscape Ssi-1000/Ssi-5000 Ultrasound TransducersSonoscape Company Limited · 2005
- This deviceK091877 Chison Digital Color Doppler Ultrasound System, Convex Probe, Linear…Chison Medical Imaging Co., Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933202 | Venus Diagnostic Ultrasound System | GE Medical Systems | 1994 | — |
| −4 | K970901 | GE Logiq 500 Diagnostic Ultrasound System | GE Medical Systems | 1997 | — |
| −3 | K991611 | GE Logiq 500 | General Electric Co. | 1999 | — |
| −2 | K042369 | Sonoscape Ultrasound System Ssi-1000/Ssi-5000 | Sonoscape Company Limited | 2004 | — |
| −1 | K052042 | Sonoscape Ssi-1000/Ssi-5000 Ultrasound Transducers | Sonoscape Company Limited | 2005 | — |
| 0 (this device) | K091877 | Chison Digital Color Doppler Ultrasound System, Convex Probe, Linear Probe… | Chison Medical Imaging Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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 |
|---|---|---|---|
| * | K052042 | Sonoscape Ssi-1000/Ssi-5000 Ultrasound TransducersSummary page 1…892.1560 90-1YO Diagnostic ultrasonic transducer 892.1570 90-ITX 2. Marketed Device: K052042, SonoScape SSI-1000 ultrasound system 3. Device Description: The CHISON Q3/Q5/Q6/Q8/iVis6O/iVis6O EXPERT ultrasound system is… | 2005 |
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 15 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K052042.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen; Pediatric; Small Organ (breast, tests, thyroid); Heart Soft Tissue; Peripheral Vascular; Musculo-skeletal (conventional) and Urology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091877 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091877: Chison Digital Color Doppler Ultrasound System, Convex Probe, Linear Probe, Phased Array Probe, Transvaginal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091877
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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