510(k) · Cleared
ClearedTrinity/3D Prostate Suite
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 30, 2017 as substantially equivalent to K160357 (Koelis, 2016) and 1 other predicate after a 97-day review. Its family tree reaches back 22 generations to 1995.
- Decided
- May 30, 2017
- Review
- 97 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 22 generations to K935595 (1995). 184 ancestors in all, the oldest K863700 (1987). No later device cites it as a predicate yet.
- Root · 22 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations between
- 3 generations backK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- 2 generations backK152195 Logiq S8GE Healthcare · 2015
- 1 generation backK160182 LOGIQ S7 ExpertGE Healthcare · 2016 · Recalled
- This deviceK170521 Trinity/3D Prostate SuiteKoelis · 2017
Show all 22 generations
- Root · 22 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 21 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 20 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 19 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 18 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 17 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 16 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 15 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 14 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 13 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 12 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 11 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 10 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 9 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 8 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 7 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 6 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 5 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 4 generations backK141639 Voluson S6, Voluson S8GE Healthcare · 2014
- 3 generations backK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- 2 generations backK152195 Logiq S8GE Healthcare · 2015
- 1 generation backK160182 LOGIQ S7 ExpertGE Healthcare · 2016 · Recalled
- This deviceK170521 Trinity/3D Prostate SuiteKoelis · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −21 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −20 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −19 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −18 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −17 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −16 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −15 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −14 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −13 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −12 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −11 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −10 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −9 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −8 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −7 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −6 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −5 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −4 | K141639 | Voluson S6, Voluson S8 | GE Healthcare | 2014 | — |
| −3 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| −2 | K152195 | Logiq S8 | GE Healthcare | 2015 | — |
| −1 | K160182 | LOGIQ S7 Expert | GE Healthcare | 2016 | 1 |
| 0 (this device) | 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 | 8 | 0 |
| 2000 | 8 | 0 |
| 2001 | 7 | 0 |
| 2002 | 11 | 0 |
| 2003 | 15 | 0 |
| 2004 | 15 | 0 |
| 2005 | 12 | 0 |
| 2006 | 10 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 5 | 0 |
| 2012 | 10 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K160357 | TrinitySummary page 11…(21CFR 892.2050) IYN (21CFR 892.1550) IYO (21CFR 892.1560) ITX (21CFR 892.1570) Cleared Device: The TRINITY is substantially equivalent to: 510(k) Number Device Name K160357 TRINITY K160182 Logiq S7 expert TITLE 510 (K) SUMMARY ID | K170521 Page 1 of 5 | | [ o] 510 (K) SUMMARY 6 KOELI… | 2016 |
| * | K160182 | LOGIQ S7 ExpertSummary page 11…IYN (21CFR 892.1550) IYO (21CFR 892.1560) ITX (21CFR 892.1570) Cleared Device: The TRINITY is substantially equivalent to: 510(k) Number Device Name K160357 TRINITY K160182 Logiq S7 expert TITLE 510 (K) SUMMARY ID | K170521 Page 1 of 5 | | [ o] 510 (K) SUMMARY 6 KOELIS 510(k) Number:… | 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 22 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 57 of the 184 ancestors have a recall of any class.
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. 2017, 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?
Ultrasound System TRINITY and its embedded 3D PROSTATE SUITE software are intended to be used by clinicians and their assistants, qualified to perform ultrasound diagnosis and ultrasound-guided procedures, in public or private hospitals. TRINITY is indicated to: * Generate ultrasound images for structural analysis and fluid flow analysis for o urology, o gynecology, o vascular, o abdominal, o small organs, o soft tissues and o musculoskeletal exams…
Read the full statement (148 words)
Ultrasound System
TRINITY and its embedded 3D PROSTATE SUITE software are intended to be used by clinicians and their assistants, qualified to perform ultrasound diagnosis and ultrasound-guided procedures, in public or private hospitals.
TRINITY is indicated to:
* Generate ultrasound images for structural analysis and fluid flow analysis for
o urology,
o gynecology,
o vascular,
o abdominal,
o small organs,
o soft tissues and
o musculoskeletal
exams
TRINITY is not indicated for ophthalmic and cranial ultrasonography.
Medical Imaging Processing System
3D-PROSTATE SUITE, embedded on TRINITY or other KOELIS systems that do not integrate a 3D ultrasound module,
is indicated to:
* Process, visualize and record various 2D and 3D image modalities (such as Ultrasound images, MRI)
* Fuse images of various modalities
* Display organ and perform measurements
* Display cartographies of prostate interventions (instrument positions)
» Manage patient data
* Import and export of data and images
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/K170521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170521: Trinity/3D Prostate Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170521
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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