510(k) · Cleared
ClearedTINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Tingsn Technology Co., Ltd. · OBJ Catheter, Ultrasound, Intravascular
Cleared on Jul 19, 2025 as substantially equivalent to K221148 (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, 2022) and 1 other predicate after a 114-day review. Its family tree reaches back 27 generations to 1995.
- Decided
- Jul 19, 2025
- Review
- 114 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 27 generations to K935595 (1995). 280 ancestors in all, the oldest K850478 (1985). No later device cites it as a predicate yet.
- Root · 27 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 23 generations between
- 3 generations backK181727 Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- 2 generations backK200708 Vivid iqGe Medical Systems Ultrasound And · 2020
- 1 generation backK221148 Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2022
- This deviceK250913 TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd. · 2025
Show all 27 generations
- Root · 27 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 26 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 25 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 24 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 23 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 22 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 21 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 20 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 19 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 18 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 17 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 16 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 15 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 14 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 13 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 12 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 11 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 10 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 9 generations backK141639 Voluson S6, Voluson S8GE Healthcare · 2014
- 8 generations backK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- 7 generations backK161047 LOGIQ P9 and LOGIQ P7GE Healthcare · 2016
- 6 generations backK163596 LOGIQ P9 and LOGIQ P7GE Healthcare · 2017
- 5 generations backK170714 VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017
- 4 generations backK180599 VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- 3 generations backK181727 Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- 2 generations backK200708 Vivid iqGe Medical Systems Ultrasound And · 2020
- 1 generation backK221148 Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2022
- This deviceK250913 TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −26 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −25 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −24 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −23 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −22 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −21 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −20 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −19 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −18 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −17 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −16 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −15 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −14 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −13 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −12 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −11 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −10 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −9 | K141639 | Voluson S6, Voluson S8 | GE Healthcare | 2014 | — |
| −8 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| −7 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
| −6 | K163596 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2017 | — |
| −5 | K170714 | Venue | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017 | — |
| −4 | K180599 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| −3 | K181727 | Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| −2 | K200708 | Vivid iq | Ge Medical Systems Ultrasound And | 2020 | — |
| −1 | K221148 | Vivid iq | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2022 | — |
| 0 (this device) | K250913 | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System | Jiangsu Tingsn Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 10 | 0 |
| 1996 | 6 | 0 |
| 1997 | 11 | 0 |
| 1998 | 6 | 0 |
| 1999 | 16 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 14 | 0 |
| 2003 | 16 | 0 |
| 2004 | 19 | 0 |
| 2005 | 13 | 0 |
| 2006 | 15 | 0 |
| 2007 | 15 | 0 |
| 2008 | 9 | 0 |
| 2009 | 8 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 13 | 0 |
| 2013 | 5 | 0 |
| 2014 | 10 | 0 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 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 OBJ? 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 OBJ device
- #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 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 |
|---|---|---|---|
| * | K221148 | Vivid iqSummary page 5…OBJ,IYN,IYO,ITX 3. PREDICATE DEVICE TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System（The ultrasound console）： Predicate Device：GE Vivid iq (K221148) Reference Device：Clivia series Diagnostic Ultrasound System(K211886) Common name: Ultrasonic pulsed doppler… | 2022 |
| * | K092064 | Soundstar 3D Ultrasound Catheter, Model M-5723-12Summary page 6…emarket Notification Submission TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System (The ultrasound catheter)： Predicate Device：SOUNDSTAR 3D Ultrasound Catheter(K092064) Common name: Catheter, ultrasound, intravascular Regulation number 21 CFR 870.1200 Regulati… | 2009 |
| † | K211886 | Clivia series Diagnostic Ultrasound System | 2021 |
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 30 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 71 of the 280 ancestors have a recall of any class.
- 1 other device also cites its predicate K221148.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OBJ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBJ
35in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBJ
2in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OBJ
791in 2025
MAUDE reports naming product code OBJ, 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 | 3 | 74 | 0 | 0 |
| 2008 | 6 | 100 | 0 | 6 |
| 2009 | 3 | 108 | 0 | 22 |
| 2010 | 1 | — | 0 | 39 |
| 2011 | 4 | 109 | 0 | 47 |
| 2012 | 3 | 136 | 0 | 53 |
| 2013 | 4 | 96 | 0 | 328 |
| 2014 | 3 | 30 | 0 | 609 |
| 2015 | 4 | 131 | 2 | 401 |
| 2016 | 4 | 94 | 0 | 515 |
| 2017 | 6 | 45 | 2 | 524 |
| 2018 | 2 | — | 2 | 542 |
| 2019 | 1 | — | 0 | 237 |
| 2020 | 4 | 135 | 2 | 288 |
| 2021 | 3 | 29 | 0 | 353 |
| 2022 | 3 | 63 | 0 | 473 |
| 2023 | 3 | 63 | 0 | 697 |
| 2024 | 3 | 131 | 0 | 1,154 |
| 2025 | 7 | 35 | 0 | 791 |
| 2026 | 4 | 81 | 1 (1) | — |
What is it indicated for?
TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. Modes of operation include: B,M, Color Doppler,PW Doppler, CW Doppler,Power Doppler; Combined modes: B/M,B/Color,B/M/Color, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power. The device is intended for use in…
Read the full statement (110 words)
TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients.
Modes of operation include: B,M, Color Doppler,PW Doppler, CW Doppler,Power Doppler; Combined modes: B/M,B/Color,B/M/Color, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power.
The device is intended for use in Professional healthcare facility environment including echo lab, other hospital settings, operating room, Cath lab and EP lab.
The intended users of the Device is to be used exclusively by physicians who are appropriately trained personnel in a fully equipped electrophysiology or catheterization room or under their direct supervision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250913: TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250913
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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