# K142054: Imacor Zura Evo Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Imacor, Inc.
- Decided: Sep 29, 2014 after 62 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: 14 generations back to K935595 (1995). 109 ancestors in all.
No later device cites it as a predicate yet.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080223: Zura Tee System, Imacor, LLC (2008) Summary page 4.
- K100989: Zura Tee System with Claritee Probe, Imacor, Inc. (2010) Summary page 4.
- K102997: Sonixtablet Ultrasound Scanner, Ultrasonix Medical Corporation (2010) Summary page 7.

## 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
1. The Zura-EVO System is intended for the following applications: Cardiac and , Transesophageal. Measurement and calculation packages that provide information of anatomical structures that may be used by a physician for clinical diagnosis purposes. 2. When used with the ClariTEE probe -- The episodic assessment of cardiac function using transesophageal echocardiography (TEE). It is indicated for use in clinical settings including long term settings such as the ICU for an indwelling time not to exceed 72 hrs. 3. When used with the TTE probe is intended for imaging and assessment of Cardiac anatomy and function

Source page: https://510kreport.com/device/K142054
Methodology: https://510kreport.com/methodology