# K140639: Prosound F75  Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Aloka Medical, Ltd.
- Decided: Apr 16, 2014 after 35 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: 6 generations back to K954022 (1996). 11 ancestors in all.
60 later devices descend from it; 1 cites it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123828: Prosound F75 Diagnostic Ultrasound System, Hitachi Aloka Medical, Ltd. (2013) Summary page 5.

## Most influential descendants
- K153539: RS80A Diagnostic Ultrasound System (2016), 59 descendants of its own
- K163691: HS70A Diagnostic Ultrasound System (2017), 58 descendants of its own
- K173204: RS85 Diagnostic Ultrasound System (2018), 39 descendants of its own
- K170493: HS50 / HS60 Diagnostic Ultrasound System (2017), 37 descendants of its own
- K172129: HS40 Diagnostic Ultrasound System (2017), 35 descendants of its own

## Indications for use
The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult - TEE; Cardiac Neonatal; Cardiac Pediatric; Cardiac Pediatric - TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications.

Source page: https://510kreport.com/device/K140639
Methodology: https://510kreport.com/methodology