Hitachi Aloka Medical, Ltd.

• IYN — Radiology5 devices
• ITX — Radiology1 device

• Z-1696-2017 — Prosound F75 or F75 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; 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 applicationsClass II·Terminated·2014-06-11

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K142368 — NOBLUS DIAGNOSTIC ULTRASOUND SCANNERCode IYN·2015-01-14
• K140854 — INTRA-OPERATIVE ULTRASOUND TRANSDUCERCode ITX·2014-06-11
• K140639 — PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEMCode IYN·2014-04-16
• K130308 — NOBLUS ULTRASOUND DIAGNOSTIC SYSTEMCode IYN·2013-04-05
• K123828 — PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEMCode IYN·2013-01-18
• K122341 — PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37Code IYN·2012-09-26