510(k) · Cleared
ClearedSonix Ultrasound Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultrasonix Medical Corporation · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 4, 2006 as substantially equivalent to K020630 (Ultrasonix Medical Corporation, 2002) and 2 other predicates after a 37-day review. Its family tree reaches back 3 generations to 1995. 586 later devices descend from it.
- Decided
- Aug 4, 2006
- Review
- 37 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K935595 (1995). 4 ancestors in all. 586 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 2 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 1 generation backK020630 Ultrasonix Ergosonix 500 Ultrasound ScannerUltrasonix Medical Corporation · 2002
- This deviceK061827 Sonix Ultrasound ScannerUltrasonix Medical Corporation · 2006
- Descendant · cites it directly · 584 of its ownK080935 Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008
- Descendant · cites it directly · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- Descendant · 2 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- Descendant · 3 generations on · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled
- Descendant · 4 generations on · 469 of its ownK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
Showing 5 of 586 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 586 · See all- K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008 · cites it directly584descendants
- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · cites it directly582descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 2 generations on569descendants
- K110943Logiq E9GE Healthcare · 2011 · 3 generations on472descendants
- K113690GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · 4 generations on469descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −2 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −1 | K020630 | Ultrasonix Ergosonix 500 Ultrasound Scanner | Ultrasonix Medical Corporation | 2002 | — |
| 0 (this device) | K061827 | Sonix Ultrasound Scanner | Ultrasonix Medical Corporation | 2006 | — |
| +1 | K080935 | Sonix MDP Ultrasound Scanner | Ultrasonix Medical Corporation | 2008 | — |
| +1 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| +2 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| +3 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| +4 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 10 | 0 |
| 2012 | 20 | 0 |
| 2013 | 19 | 0 |
| 2014 | 34 | 0 |
| 2015 | 29 | 0 |
| 2016 | 37 | 0 |
| 2017 | 49 | 0 |
| 2018 | 48 | 0 |
| 2019 | 36 | 0 |
| 2020 | 52 | 0 |
| 2021 | 38 | 0 |
| 2022 | 43 | 0 |
| 2023 | 38 | 0 |
| 2024 | 45 | 0 |
| 2025 | 47 | 0 |
| 2026 | 31 | 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? (3)
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 |
|---|---|---|---|
| * | K020630 | Ultrasonix Ergosonix 500 Ultrasound ScannerSummary page 2…Page 7 of 37 2.4 Classification Class Ila 2.5 Predicate Device: Ultrasonix Ergosonix 500 Ultrasound Scanner (K020630) ATL HDI 5000 System (K002003) Acuson Sequoia (K973767) 2.6 Reason for submission: Clearance request for:… | 2002 |
| * | K002003 | Hdi 5000 Ultrasound System with Extended Field of View ImagingSummary page 2…Page 7 of 37 2.4 Classification Class Ila 2.5 Predicate Device: Ultrasonix Ergosonix 500 Ultrasound Scanner (K020630) ATL HDI 5000 System (K002003) Acuson Sequoia (K973767) 2.6 Reason for submission: Clearance request for: * UPS * Wireles… | 2000 |
| * | K973767 | Harmonic Imaging with ContrastSummary page 2…=== 2.4 Classification Class Ila 2.5 Predicate Device: Ultrasonix Ergosonix 500 Ultrasound Scanner (K020630) ATL HDI 5000 System (K002003) Acuson Sequoia (K973767) 2.6 Reason for submission: Clearance request for: * UPS * Wireless * Barcode rea… | 1997 |
What descends from it? (586)
See all 5863 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 11 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K080935 (Ultrasonix Medical Corporation, 2008) has gone furthest, with 584 descendants of its own.
- 2 other devices also cite its predicate K020630.
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.
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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows Diagnostic ultrasound imaging or fluid flow…
Read the full statement (182 words)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061827: Sonix Ultrasound Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061827
Report an extraction error
Are you the manufacturer?
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