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510(k) K002784

ALOKA UST-5280-5 by Aloka Co., Ltd. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2000
Date Received
September 6, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Aloka Co., Ltd.

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  • K093488 — ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM (November 20, 2009)
  • 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)

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