510(k) · Cleared
Recalled · Class II · 2024Zura Tee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imacor, LLC · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jun 24, 2008 as substantially equivalent to K042326 (Ultrasonix Medical Corporation, 2004) and 2 other predicates after a 147-day review. Its family tree reaches back 4 generations to 1995. 583 later devices descend from it. It has been recalled once.
- Decided
- Jun 24, 2008
- Review
- 147 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K935595 (1995). 16 ancestors in all. 583 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 3 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 2 generations backK020630 Ultrasonix Ergosonix 500 Ultrasound ScannerUltrasonix Medical Corporation · 2002
- 1 generation backK042326 Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerUltrasonix Medical Corporation · 2004
- This deviceK080223 Zura Tee SystemImacor, LLC · 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 583 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 583 · 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 |
|---|---|---|---|---|---|
| −4 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −3 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −2 | K020630 | Ultrasonix Ergosonix 500 Ultrasound Scanner | Ultrasonix Medical Corporation | 2002 | — |
| −1 | K042326 | Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner | Ultrasonix Medical Corporation | 2004 | — |
| 0 (this device) | K080223 | Zura Tee System | Imacor, LLC | 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 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 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 | 35 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K042326 | Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerSummary page 2…Class 1I (cjWjS03 Predicate Devices Ultrasonix Modulo (K042326) Sonosite Ultrasound Diagnostic System (K043559) GE Vivid 7 (K05 1449) Intended Use / Indications for Use The ImaCor Zura TEE… | 2004 |
| * | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Summary page 2…(cjWjS03 Predicate Devices Ultrasonix Modulo (K042326) Sonosite Ultrasound Diagnostic System (K043559) GE Vivid 7 (K05 1449) Intended Use / Indications for Use The ImaCor Zura TEE System is intended for use in the episodic asses… | 2005 |
| * | K051449 | GE Vivid 7 with or Without SuffixSummary page 2…(cjWjS03 Predicate Devices Ultrasonix Modulo (K042326) Sonosite Ultrasound Diagnostic System (K043559) GE Vivid 7 (K05 1449) Intended Use / Indications for Use The ImaCor Zura TEE System is intended for use in the episodic assessment of cardiac funct… | 2005 |
What descends from it? (583)
See all 5834 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2024 | Class II | Z-0231-2025 | Process control | Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K083095 (Ultrasonix Medical Corporation, 2008) has gone furthest, with 582 descendants of its own.
- 4 other devices also cite its predicate K042326.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The ImaCor Zura TEE System is intended for use in the episodic assessment of cardiac function using transesophageal echocardiography. It is indicated for use in clinical settings, including long-term settings such as the ICU, for an indwelling time period not to exceed 72 hours. The ImaCor Zura TEE System is not intended for pediatric use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080223 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080223: Zura Tee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080223
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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