510(k) · Cleared
ClearedVersana Premier
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 Nov 21, 2018 as substantially equivalent to K160277 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2016) and 4 other predicates after a 91-day review. Its family tree reaches back 22 generations to 1995. 8 later devices descend from it.
- Decided
- Nov 21, 2018
- Review
- 91 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 22 generations to K935595 (1995). 196 ancestors in all, the oldest K850478 (1985). 8 later devices descend from it, 3 citing it directly.
- Root · 22 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations between
- 3 generations backK152567 Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare · 2015
- 2 generations backK160184 Voluson S6, Voluson S8, Voluson S10GE Healthcare · 2016 · Recalled
- 1 generation backK161706 Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016
- This deviceK182277 Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- Descendant · cites it directly · 3 of its ownK191792 Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019
- Descendant · cites it directly · 2 of its ownK200138 Versana PremierGe Medical Systems Ultrasound And · 2020
- Descendant · 2 generations on · 1 of its ownK220446 Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics · 2022
- Descendant · 2 generations on · 1 of its ownK210438 Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics · 2021
- Descendant · cites it directly · 1 of its ownK191798 Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019
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 backK142472 Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare · 2015
- 3 generations backK152567 Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare · 2015
- 2 generations backK160184 Voluson S6, Voluson S8, Voluson S10GE Healthcare · 2016 · Recalled
- 1 generation backK161706 Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016
- This deviceK182277 Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019 · cites it directly3descendants
- K200138Versana PremierGe Medical Systems Ultrasound And · 2020 · cites it directly2descendants
- K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics · 2022 · 2 generations on1descendant
- K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics · 2021 · 2 generations on1descendant
- K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019 · cites it directly1descendant
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 | K142472 | Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems | GE Healthcare | 2015 | — |
| −3 | K152567 | Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System | GE Healthcare | 2015 | — |
| −2 | K160184 | Voluson S6, Voluson S8, Voluson S10 | GE Healthcare | 2016 | 1 |
| −1 | K161706 | Vivid iq | Ge Medical Systems Ultrasound and Primary Care Diagnostics L | 2016 | — |
| 0 (this device) | K182277 | Versana Premier | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| +1 | K191792 | Versana Balance | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019 | — |
| +1 | K200138 | Versana Premier | Ge Medical Systems Ultrasound And | 2020 | — |
| +2 | K220446 | Versana Balance | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022 | — |
| +2 | K210438 | Versana Premier | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021 | — |
| +1 | K191798 | Versana Active | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 8 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 11 | 0 |
| 2003 | 15 | 0 |
| 2004 | 15 | 0 |
| 2005 | 12 | 0 |
| 2006 | 10 | 0 |
| 2007 | 7 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 6 | 0 |
| 2012 | 11 | 0 |
| 2013 | 4 | 0 |
| 2014 | 10 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (5)
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 |
|---|---|---|---|
| * | K160277 | LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6Summary page 6…Non-vascular access N N N N [8] N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596; P2= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previou… | 2016 |
| * | K163596 | LOGIQ P9 and LOGIQ P7Summary page 6…N N N [8] N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596; P2= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078 Notes:… | 2017 |
| * | K151028 | LOGIQ eSummary page 6…N N N [8] N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596; P2= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078 Notes: [1] Abdominal includes GYN and Urologic… | 2015 |
| * | K161706 | Vivid iqSummary page 6…[8] N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596; P2= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078 Notes: [1] Abdominal includes GYN and Urological/Prostate; [2] Small Organ… | 2016 |
| * | K160078 | Vivid T8Summary page 6…leared by FDA K160277; P1= previously cleared by FDA K163596; P2= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078 Notes: [1] Abdominal includes GYN and Urological/Prostate; [2] Small Organ includes breast, testes, thyroid;… | 2016 |
| † | K180995 | Vscan Extend | 2018 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 58 of the 196 ancestors have a recall of any class.
- Of its descendants, K191792 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2019) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K160277.
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. 2018, 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 Premier are general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability and clinical applications including: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, testes, thyroid), Cardiac, Peripheral Vascular, Musculos-keletal Conventional, Musculos-keletal Superficial, Transcranial, Transrectal, Transvaginal, Tissue Biopsy/Fluid Drainage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182277 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182277: Versana Premier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182277
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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