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510(k) K140639

PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM by Hitachi Aloka Medical, Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2014
Date Received
March 12, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

Other clearances by Hitachi Aloka Medical, Ltd.

  • K142368 — NOBLUS DIAGNOSTIC ULTRASOUND SCANNER (January 14, 2015)
  • K140854 — INTRA-OPERATIVE ULTRASOUND TRANSDUCER (June 11, 2014)
  • 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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