# K202074: Apache Ultrasound System (Model C62)

- Pathway: 510(k) (Traditional)
- Applicant: Compal Electronics, Inc.
- Decided: Nov 12, 2020 after 108 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 5.

## Indications for use
The Apache Ultrasound System (Model: C62) is intended for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional), Urology, and Pediatric. The system provides diagnostic ultrasound imaging in B, Color Doppler, and M 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/K202074
Methodology: https://510kreport.com/methodology