510(k) · Cleared
ClearedImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imsonic Medical China, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Nov 11, 2022 as substantially equivalent to K152209 (FUJIFILM Sonosite, Inc., 2015) after a 221-day review. Its family tree reaches back 12 generations to 1995.
- Decided
- Nov 11, 2022
- Review
- 221 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K945773 (1995). 54 ancestors in all, the oldest K891689 (1989). No later device cites it as a predicate yet.
- Root · 12 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 8 generations between
- 3 generations backK133454 Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013
- 2 generations backK142017 X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2014
- 1 generation backK152209 FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015
- This deviceK220983 ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc. · 2022
Show all 12 generations
- Root · 12 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 11 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 10 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- 9 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 8 generations backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 7 generations backK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007 · Recalled
- 6 generations backK082098 Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · Recalled
- 5 generations backK113156 Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · Recalled
- 4 generations backK130173 Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013 · Recalled
- 3 generations backK133454 Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013
- 2 generations backK142017 X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2014
- 1 generation backK152209 FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015
- This deviceK220983 ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −11 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −10 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| −9 | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 4 |
| −8 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| −7 | K071134 | Sonosite Maxx Series Diagnostic Ultrasound System | Sonosite,Inc. | 2007 | 2 |
| −6 | K082098 | Sonosite Maxx Series Ultrasound System | Sonosite,Inc. | 2008 | 2 |
| −5 | K113156 | Sonosite Edge Ultrasound System | Sonosite,Inc. | 2011 | 1 |
| −4 | K130173 | Sonosite Maxx Series Ultrasound System | FUJIFILM Sonosite, Inc. | 2013 | 1 |
| −3 | K133454 | Sonosite Edge Ultrasound System | FUJIFILM Sonosite, Inc. | 2013 | — |
| −2 | K142017 | X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2014 | — |
| −1 | K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2015 | — |
| 0 (this device) | K220983 | ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System | Imsonic Medical China, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K152209 | FUJIFILM SonoSite X-Porte Ultrasound SystemSummary page 4…Ultrasound System Predicate Manufacturer: Device: FUJIFILM Sonosite, Inc. 510(k) Clearance: K152209 (08/19/2015) Reference Trade Name: CX50 Diagnostic Ultrasound System device: Manufacturer:… | 2015 |
| † | K162329 | CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System | 2016 |
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 27 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 13 of the 54 ancestors have a recall of any class.
- 3 other devices also cite its predicate K152209.
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. 2022, 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?
ImSonic TR-1 Ultrasonic pulsed doppler imaging system is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. The system is intended to be used in a hospital or clinic setting. Specific clinical applications and exam types include: Fetal/obstetric Gynecological /Pelvic Abdominal Renal Cardiac Pediatric Small organ (thyroid…
Read the full statement (100 words)
ImSonic TR-1 Ultrasonic pulsed doppler imaging system is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. The system is intended to be used in a hospital or clinic setting. Specific clinical applications and exam types include:
Fetal/obstetric
Gynecological /Pelvic
Abdominal
Renal
Cardiac
Pediatric
Small organ (thyroid, breast, testes, etc.)
Musculoskeletal (conventional & superficial)
Peripheral vascular
Ophthalmic
Modes of operation include B, M, PWD(PW), Color Doppler (C ), B+M, B+Color Doppler, B+PWD, Biopsy, Harmonics (Tissue), Contrast Imaging (CPS), Steered Spatial Compounding (SSC).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220983 · printed Nov 5, 2026
Cite this page
510(k) Report. “K220983: ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K220983
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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