# K080223: Zura Tee System

- Pathway: 510(k) (Traditional)
- Applicant: Imacor, LLC
- Decided: Jun 24, 2008 after 147 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K935595 (1995). 16 ancestors in all.
583 later devices descend from it; 4 cite it directly.
0 of 600 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042326: Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner, Ultrasonix Medical Corporation (2004) Summary page 2.
- K043559: Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series), Sonosite,Inc. (2005) Summary page 2.
- K051449: GE Vivid 7 with or Without Suffix, GE Medical Systems (2005) Summary page 2.

## Most influential descendants
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own
- K110943: Logiq E9 (2011), 472 descendants of its own
- K113690: GE Logiq I, Logiq E and Vivid E (2011), 469 descendants of its own
- K111582: Logiq S8 (2011), 367 descendants of its own

## Recalls of this device
- Sep 16, 2024 · Class II · Z-0231-2025: 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 f

## Indications for use
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.

Source page: https://510kreport.com/device/K080223
Methodology: https://510kreport.com/methodology