510(k) · Cleared
ClearedSonix MDP 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 6, 2008 as substantially equivalent to K053069 (Sonosite,Inc., 2005) and 4 other predicates after a 126-day review. Its family tree reaches back 5 generations to 1995. 584 later devices descend from it.
- Decided
- Aug 6, 2008
- Review
- 126 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K945773 (1995). 27 ancestors in all, the oldest K935595 (1995). 584 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 4 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 3 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- 2 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 1 generation backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- This deviceK080935 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
- Descendant · 3 generations on · 367 of its ownK111582 Logiq S8GE Healthcare · 2011 · Recalled
Showing 5 of 584 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 584 · See all- 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
- K111582Logiq S8GE Healthcare · 2011 · 3 generations on367descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −4 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −3 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| −2 | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 4 |
| −1 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| 0 (this device) | 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 |
| +3 | K111582 | Logiq S8 | GE Healthcare | 2011 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1997 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 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? (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 |
|---|---|---|---|
| * | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Summary page 2…Page 7 of 35 2.4 Classification Class II 2.5 Predicate Device: SonoSite MicroMaxx High Resolution Ultrsound System (K053069) Ultrasonix Ergosonix 500 Ultrasound Scanner (K042326) SONIX Ultrasound Scanner (K061827) Philips HD 11 Diagnostic Ultra… | 2005 |
| * | K042326 | Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerSummary page 2…= 2.4 Classification Class II 2.5 Predicate Device: SonoSite MicroMaxx High Resolution Ultrsound System (K053069) Ultrasonix Ergosonix 500 Ultrasound Scanner (K042326) SONIX Ultrasound Scanner (K061827) Philips HD 11 Diagnostic Ultrasound System (K062247) GE Logiq P5 and A5 (K060993) 2… | 2004 |
| * | K061827 | Sonix Ultrasound ScannerSummary page 2…Predicate Device: SonoSite MicroMaxx High Resolution Ultrsound System (K053069) Ultrasonix Ergosonix 500 Ultrasound Scanner (K042326) SONIX Ultrasound Scanner (K061827) Philips HD 11 Diagnostic Ultrasound System (K062247) GE Logiq P5 and A5 (K060993) 2.6 Reason for submission: Name c… | 2006 |
| * | K062247 | HD11 Diagnostic Ultrasound SystemSummary page 2…Ultrsound System (K053069) Ultrasonix Ergosonix 500 Ultrasound Scanner (K042326) SONIX Ultrasound Scanner (K061827) Philips HD 11 Diagnostic Ultrasound System (K062247) GE Logiq P5 and A5 (K060993) 2.6 Reason for submission: Name change request N/A New product clearance for:… | 2006 |
| * | K060993 | GE Logiq P5 and A5Summary page 2…ltrasonix Ergosonix 500 Ultrasound Scanner (K042326) SONIX Ultrasound Scanner (K061827) Philips HD 11 Diagnostic Ultrasound System (K062247) GE Logiq P5 and A5 (K060993) 2.6 Reason for submission: Name change request N/A New product clearance for: SONIX MDP Ultraso… | 2006 |
What descends from it? (584)
See all 5844 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 13 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 27 ancestors have a recall of any class.
- Of its descendants, K083095 (Ultrasonix Medical Corporation, 2008) has gone furthest, with 582 descendants of its own.
- 12 other devices also cite its predicate K053069.
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. 2008, 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 SONIX MDP Ultrasound System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculo- skeletal superficial, Pelvic, Nerve Block, Vascular Access. The system also provides the ability to measure anatomical…
Read the full statement (90 words)
The SONIX MDP Ultrasound System is intended for the following applications:
Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological,
Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Transesophageal,
Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculo-
skeletal superficial, Pelvic, Nerve Block, Vascular Access.
The system also provides the ability to measure anatomical structures {fetal, abdominal,
pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculo-
skeletal) and provides calculation packages that provide information to the clinician that
may be used adjunctively with other medical data obtained by a physician for clinical
diagnosis purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080935 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080935: Sonix MDP Ultrasound Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080935
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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