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510(k) K130308

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2013
Date Received
February 7, 2013
Clearance Type
Special
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)
  • K140639 — PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM (April 16, 2014)
  • 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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