# K170870: Site~Rite Halcyon Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Chison Medical Imaging Co., Ltd.
- Decided: Jul 6, 2017 after 105 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: 11 generations back to K863700 (1987). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121867: Sonotouch Series Diagnostic Ultrasound Systems, Chison Medical Imaging Co., Ltd. (2012) Summary page 8.

## Indications for use
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified clinician for evaluation of Fetal/OB, Abdominal (GYN & Urology), Pediatric, Small Organ (breast, testes, thyroid), Cardiac (Adult & Pediatric), Peripheral Vascular, Vascular Access, Musculo-skeletal Conventional & Superficial.

Source page: https://510kreport.com/device/K170870
Methodology: https://510kreport.com/methodology