# K150045: S30/S40 Digital Color Doppler Ultraound System - Pathway: 510(k) (Traditional) - Applicant: Sonoscape Company Limited - Decided: Apr 28, 2015 after 106 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: 20 generations back to K935595 (1995). 208 ancestors in all. 17 later devices descend from it; 1 cites it directly. 6 of 226 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K132527: Digital Color Doppler Ultasound System, Sonoscape Company Limited (2013) Summary page 35. - K131213: Digital Color Doppler Ultrasound System, Sonoscape Company Limited (2013) Summary page 35. - K142710: S9 Portable Digital Color Doppler Ultrasound System, Sonoscape Company Limited (2015) Summary page 35. ## Most influential descendants - K152854: S50 Digital Color Doppler Ultrasound System (2016), 16 descendants of its own - K160283: S45 Digital Color Doppler Ultrasound System (2016), 15 descendants of its own - K172082: S60 Series Digital Color Doppler Ultrasound System (2017), 5 descendants of its own - K201059: S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System (2020), 4 descendants of its own - K170999: P50 Series Digital Color Doppler Ultrasound System (2017), 4 descendants of its own ## Indications for use The SonoScape S30/S40 system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology. Source page: https://510kreport.com/device/K150045 Methodology: https://510kreport.com/methodology