510(k) · Cleared
ClearedTrinity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koelis · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on May 2, 2016 as substantially equivalent to K141261 (GE Healthcare, 2014) and 1 other predicate after an 84-day review. Its family tree reaches back 18 generations to 1995. 1 later device descends from it.
- Decided
- May 2, 2016
- Review
- 84 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K935595 (1995). 134 ancestors in all, the oldest K863700 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations between
- 3 generations backK122114 Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2012 · Recalled
- 2 generations backK131527 Logiq S8GE Healthcare · 2013
- 1 generation backK141261 Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2014
- This deviceK160357 TrinityKoelis · 2016
- Descendant · cites it directly · 0 of its ownK170521 Trinity/3D Prostate SuiteKoelis · 2017
Show all 18 generations
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 17 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 16 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 15 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 14 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 13 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 12 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 10 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 9 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 8 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 7 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 6 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 5 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 4 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 3 generations backK122114 Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2012 · Recalled
- 2 generations backK131527 Logiq S8GE Healthcare · 2013
- 1 generation backK141261 Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2014
- This deviceK160357 TrinityKoelis · 2016
Most influential descendants
Showing 1 of 1 · See all- K170521Trinity/3D Prostate SuiteKoelis · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −17 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −16 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −15 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −14 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −13 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −12 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −10 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −9 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −8 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −7 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −6 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −5 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −4 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −3 | K122114 | Logiq S7 Expert, Logiq S7 Pro | GE Healthcare | 2012 | 1 |
| −2 | K131527 | Logiq S8 | GE Healthcare | 2013 | — |
| −1 | K141261 | Logiq S7 Expert, Logiq S7 Pro | GE Healthcare | 2014 | — |
| 0 (this device) | K160357 | Trinity | Koelis | 2016 | — |
| +1 | K170521 | Trinity/3D Prostate Suite | Koelis | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 6 | 0 |
| 1996 | 3 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 11 | 0 |
| 2004 | 12 | 0 |
| 2005 | 11 | 0 |
| 2006 | 8 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K141261 | Logiq S7 Expert, Logiq S7 ProSummary page 7…LLZ (21CFR 892.2050) Cleared Device: The device is substantially equivalent to: 510(k) Number Device Name K141261 LOGIQ S7 Expert and LOGIQ S7 Pro (GE Healthcare) K131448… | 2014 |
| * | K131448 | 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS…Summary page 7…510(k) Number Device Name K141261 LOGIQ S7 Expert and LOGIQ S7 Pro (GE Healthcare) K131448 UROSTATION - 3D PROSTATE SUITE (KOELIS) QMS TITLE Traditional 510(… | 2013 |
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 |
|---|---|---|---|
| K170521 | Trinity/3D Prostate Suite | 2017 | 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 21 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 37 of the 134 ancestors have a recall of any class.
- Of its descendants, K170521 (Koelis, 2017) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K141261.
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. 2016, 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?
TRINITY® Ultrasound and Medical Imaging Processing System is intended to be used by clinicians and their assistants.
The device is indicated to generate, visualize and record 2D and 3D ultrasound images.
In the particular context of prostate biopsy, the device embedding the 3D PROSTATE SUITE SOFTWARE is indicated to process, visualize and record 3D digital ultrasound images in a view to map the organ.
Additional features include 2D/3D image and organ display, measurement, data management, multimodal image fusion (ultrasound, MRI, etc.).
Patient population: all patients requiring an ultrasound scan or ultrasound-based intervention particularly in urology.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160357: Trinity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160357
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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