510(k) · Cleared
ClearedUltrasonix Ergosonix 500 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 Jun 13, 2002 as substantially equivalent to K002003 (Atl Ultrasound, Inc., 2000) and 1 other predicate after a 107-day review. Its family tree reaches back 2 generations to 1995. 595 later devices descend from it.
- Decided
- Jun 13, 2002
- Review
- 107 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K935595 (1995). 3 ancestors in all. 595 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 1 generation backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- This deviceK020630 Ultrasonix Ergosonix 500 Ultrasound ScannerUltrasonix Medical Corporation · 2002
- Descendant · cites it directly · 590 of its ownK042326 Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerUltrasonix Medical Corporation · 2004
- Descendant · cites it directly · 586 of its ownK061827 Sonix Ultrasound ScannerUltrasonix Medical Corporation · 2006
- Descendant · 2 generations on · 584 of its ownK080935 Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008
- Descendant · 2 generations on · 583 of its ownK080223 Zura Tee SystemImacor, LLC · 2008 · Recalled
- Descendant · 2 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
Showing 5 of 595 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 595 · See all- K042326Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerUltrasonix Medical Corporation · 2004 · cites it directly590descendants
- K061827Sonix Ultrasound ScannerUltrasonix Medical Corporation · 2006 · cites it directly586descendants
- K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008 · 2 generations on584descendants
- K080223Zura Tee SystemImacor, LLC · 2008 · 2 generations on583descendants
- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 2 generations on582descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −1 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| 0 (this device) | K020630 | Ultrasonix Ergosonix 500 Ultrasound Scanner | Ultrasonix Medical Corporation | 2002 | — |
| +1 | K042326 | Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner | Ultrasonix Medical Corporation | 2004 | — |
| +1 | K061827 | Sonix Ultrasound Scanner | Ultrasonix Medical Corporation | 2006 | — |
| +2 | K080935 | Sonix MDP Ultrasound Scanner | Ultrasonix Medical Corporation | 2008 | — |
| +2 | K080223 | Zura Tee System | Imacor, LLC | 2008 | 1 |
| +2 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 11 | 0 |
| 2012 | 21 | 0 |
| 2013 | 19 | 0 |
| 2014 | 34 | 0 |
| 2015 | 30 | 0 |
| 2016 | 37 | 0 |
| 2017 | 49 | 0 |
| 2018 | 49 | 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? (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 |
|---|---|---|---|
| * | K002003 | Hdi 5000 Ultrasound System with Extended Field of View ImagingSummary page 2…3 2.4 Classification: Class II 2.5 Predicate Device: ATL HDI 5000 System (K002003) Acuson Sequoia (K973767) 2.6 Reason for submission: New product 3.0 Device Description… | 2000 |
| * | K973767 | Harmonic Imaging with ContrastSummary page 2…2.4 Classification: Class II 2.5 Predicate Device: ATL HDI 5000 System (K002003) Acuson Sequoia (K973767) 2.6 Reason for submission: New product 3.0 Device Description The Ultrasonix Ergosonix 500 Ul… | 1997 |
What descends from it? (595)
See all 5953 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 7 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K042326 (Ultrasonix Medical Corporation, 2004) has gone furthest, with 590 descendants of its own.
- 7 other devices also cite its predicate K002003.
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?
The Ultrasonix Ergosonix 500 is intended for use in obstetrics/gynecology, general radiology examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), trans-vaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020630: Ultrasonix Ergosonix 500 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/K020630
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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