# K220490: ImaCor Zura Handheld ZHH-010

- Pathway: 510(k) (Traditional)
- Applicant: Imacor, Inc.
- Decided: Apr 8, 2022 after 45 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K935595 (1995). 324 ancestors in all.
No later device cites it as a predicate yet.
6 of 325 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192107: Clarius Ultrasound Scanner, Clarius Mobile Health Corp. (2019) Summary page 4.

## Recalls of this device
- Aug 29, 2025 · Class II · Z-0038-2026: Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
- 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 Handheld ZHH-010 is a software-based handheld ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging using the ImaCor ClariTEE probe. (Cardiac, TEE) The system is intended for use in critical care environments where healthcare is provided by trained healthcare professionals. It is not for pediatric use (Less than 18 years of age) It is not for use in EMS settings.

Source page: https://510kreport.com/device/K220490
Methodology: https://510kreport.com/methodology