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510(k) K140854

INTRA-OPERATIVE ULTRASOUND TRANSDUCER by Hitachi Aloka Medical, Ltd. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2014
Date Received
April 3, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Hitachi Aloka Medical, Ltd.

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  • K130308 — NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM (April 5, 2013)
  • K123828 — PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM (January 18, 2013)
  • K122341 — PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 (September 26, 2012)

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