510(k) · Cleared
ClearedACUSON Freestyle Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Apr 10, 2020 as substantially equivalent to K162417 (Siemens Medi Cal Solutions, Inc., 2016) after a 30-day review. Its family tree reaches back 22 generations to 1995. 7 later devices descend from it.
- Decided
- Apr 10, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 22 generations to K935595 (1995). 194 ancestors in all, the oldest K863700 (1987). 7 later devices descend from it, 1 citing it directly.
- Root · 22 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations between
- 3 generations backK142876 ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- 2 generations backK152369 ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 2015
- 1 generation backK162417 Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016
- This deviceK200644 ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
- Descendant · cites it directly · 6 of its ownK202683 ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000…Siemens Medical Solutions USA, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK211726 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK242893 VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited · 2025
- Descendant · 4 generations on · 0 of its ownK261849 VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited · 2026
- Descendant · 4 generations on · 0 of its ownK260885 VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited · 2026
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 backK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- 6 generations backK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- 5 generations backK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled
- 4 generations backK140959 Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014
- 3 generations backK142876 ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- 2 generations backK152369 ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 2015
- 1 generation backK162417 Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016
- This deviceK200644 ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc. · 2020 · cites it directly6descendants
- K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2021 · 2 generations on4descendants
- K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited · 2025 · 3 generations on2descendants
- K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited · 2026 · 4 generations on0descendants
- K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited · 2026 · 4 generations on0descendants
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 | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −6 | K123001 | Acuson X700 Diagnstic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2012 | 2 |
| −5 | K132804 | Acuson S1000 / S2000 / S3000 | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013 | 3 |
| −4 | K140959 | Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −3 | K142876 | ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | 1 |
| −2 | K152369 | ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2015 | — |
| −1 | K162417 | Acuson Freestyle Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2016 | — |
| 0 (this device) | K200644 | ACUSON Freestyle Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +1 | K202683 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic… | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +2 | K211726 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +3 | K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | Luma Vision Limited | 2025 | — |
| +4 | K261849 | VERAFEYE Imaging Catheter (VF-VIC-002) | Luma Vision Limited | 2026 | — |
| +4 | K260885 | VERAFEYE Imaging and Guidance System (VF-VIS-002) | Luma Vision Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 3 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 8 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 12 | 0 |
| 2003 | 14 | 0 |
| 2004 | 16 | 0 |
| 2005 | 13 | 0 |
| 2006 | 8 | 0 |
| 2007 | 9 | 0 |
| 2008 | 9 | 0 |
| 2009 | 8 | 0 |
| 2010 | 9 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K162417 | Acuson Freestyle Ultrasound SystemSummary page 4…sculo-skeletal P P P P P Superficial Other (specify) N = new indication; P = previously cleared by K162417, Blank = Not Claimed Additional Comments: Note 1 For example: breast, testes, thyroid, penis etc. Note 2 B-mode and PW… | 2016 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202683 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System… | 2020 | 6 |
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 8 companies; a new generation was cleared every 11 months on median.
- 47 of the 194 ancestors have a recall of any class.
- Of its descendants, K202683 (Siemens Medical Solutions USA, Inc., 2020) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K162417.
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 ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body
performed by an appropriately trained healthcare professional in a healthcare setting for the following conditions:
Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).
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/K200644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200644: ACUSON Freestyle Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200644
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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