# K123828: Prosound F75 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Aloka Medical, Ltd.
- Decided: Jan 18, 2013 after 37 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954022 (1996). 10 ancestors in all.
87 later devices descend from it; 2 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110207: Aloka Prousound F75 Diagnostic Ultrasound System, Aloka Co., Ltd. (2011) Summary page 1.
- K033311: Aloka SSD-5000 V5.0 Ultrasound System, Aloka Co., Ltd. (2003) Summary page 1.
- K032875: Aloka Model SSD-5500 V6.0 Ultrasound System, Aloka Co. Ltd USA (2003) Summary page 1.

## Most influential descendants
- K140639: Prosound F75  Diagnostic Ultrasound System (2014), 60 descendants of its own
- 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

## Recalls of this device
- Jun 11, 2014 · Class II · Z-1696-2017: Loosened monitor arm.

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (Neurosurgery); 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/K123828
Methodology: https://510kreport.com/methodology