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510(k) K093488

ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM by Aloka Co., Ltd. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2009
Date Received
November 10, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Aloka Co., Ltd.

  • K111227 — ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM (May 13, 2011)
  • K110207 — ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM (February 17, 2011)
  • K083254 — ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM (December 19, 2008)
  • K081843 — ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 (July 15, 2008)
  • K080176 — ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM (February 29, 2008)
  • K072285 — ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM (August 30, 2007)
  • K060059 — ALOKA SD-3500 ULTRASOUND SYSTEM (January 13, 2006)
  • K043196 — ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM (November 30, 2004)
  • K040719 — ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM (March 26, 2004)
  • K033311 — ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM (October 29, 2003)

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