510(k) · Cleared
ClearedVersana Active
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems Ultrasound and Primary Care Diagnostics · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jun 11, 2020 as substantially equivalent to K191798 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2019) and 1 other predicate after a 56-day review. Its family tree reaches back 26 generations to 1995.
- Decided
- Jun 11, 2020
- Review
- 56 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 26 generations to K935595 (1995). 279 ancestors in all, the oldest K850478 (1985). No later device cites it as a predicate yet.
- Root · 26 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 22 generations between
- 3 generations backK180599 VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- 2 generations backK181727 Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- 1 generation backK191798 Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019
- This deviceK200998 Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
Show all 26 generations
- Root · 26 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 25 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 24 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 23 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 22 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 21 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 20 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 19 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 18 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 17 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 16 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 15 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 14 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 13 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 12 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 11 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 10 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 9 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 8 generations backK141639 Voluson S6, Voluson S8GE Healthcare · 2014
- 7 generations backK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- 6 generations backK161047 LOGIQ P9 and LOGIQ P7GE Healthcare · 2016
- 5 generations backK163596 LOGIQ P9 and LOGIQ P7GE Healthcare · 2017
- 4 generations backK170714 VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017
- 3 generations backK180599 VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- 2 generations backK181727 Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- 1 generation backK191798 Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019
- This deviceK200998 Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −25 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −24 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −23 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −22 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −21 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −20 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −19 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −18 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −17 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −16 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −15 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −14 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −13 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −12 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −11 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −10 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −9 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −8 | K141639 | Voluson S6, Voluson S8 | GE Healthcare | 2014 | — |
| −7 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| −6 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
| −5 | K163596 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2017 | — |
| −4 | K170714 | Venue | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017 | — |
| −3 | K180599 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| −2 | K181727 | Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| −1 | K191798 | Versana Active | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019 | — |
| 0 (this device) | K200998 | Versana Active | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | — |
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 | 9 | 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 | 13 | 0 |
| 2008 | 9 | 0 |
| 2009 | 7 | 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 |
| 2018 | 2 | 0 |
| 2019 | 2 | 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 |
|---|---|---|---|
| * | K191798 | Versana ActiveSummary page 4…, 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Primary Predicate Device: Versana Active (K191798) Secondary Predicate Versana Balance (K191792) Device(s): Device Description: The Versana Active… | 2019 |
| * | K191792 | Versana BalanceSummary page 4…rasound Transducer, 21 CFR 892.1570, 90-ITX Primary Predicate Device: Versana Active (K191798) Secondary Predicate Versana Balance (K191792) Device(s): Device Description: The Versana Active is a general purpose, Track 3, diagnostic… | 2019 |
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 25 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 72 of the 279 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. 2020, 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?
The Versana Active is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Active clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric)…
Read the full statement (134 words)
The Versana Active is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.
Versana Active clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Vascular/Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/ Pleural, Transcranial, Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D, 4D and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD.
The device is intended for use in an indoor hospital environment, in medical offices/clinics and other Healthcare facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200998: Versana Active.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200998
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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