510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Hitachi Aloka Medical, Ltd.

Wallingford, CT, US

Hitachi Aloka Medical, Ltd. appears in FDA device records in Wallingford, CT. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 6 510(k) clearances for Hitachi Aloka Medical, Ltd. between 2012 and 2015. The busiest year on record is 2013, with 2. The most recent is 2015, with 1.

Clearances by year, as a table
510(k) clearance decisions for Hitachi Aloka Medical, Ltd., by decision year
YearClearances
20121
20132
20142
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K142368NOBLUS DIAGNOSTIC ULTRASOUND SCANNERIYNSubstantially Equivalent
K140854INTRA-OPERATIVE ULTRASOUND TRANSDUCERITXSubstantially Equivalent
K140639PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially Equivalent
K130308NOBLUS ULTRASOUND DIAGNOSTIC SYSTEMIYNSubstantially Equivalent
K123828PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially Equivalent
K122341PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37IYNSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1696-2017Prosound 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 applicationsLoosened monitor arm.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain