# K211232: Apache Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Aco Healthcare Co., Ltd.
- Decided: Jun 25, 2021 after 63 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- 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 6.

## Indications for use
The Apache Ultrasound System is intended for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional and superficial), Small Organ (including breast, scrotum, thyroid), Peripheral Vessel, Carotid, Urology, and Pediatric. The system provides diagnostic ultrasound imaging in B, Color Doppler, M, PW and Combined (B+M; B+CD) modes. The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high. The Apache Ultrasound System is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.

Source page: https://510kreport.com/device/K211232
Methodology: https://510kreport.com/methodology