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510(k) K011457

ALOKA SSD-5500 WITH KI AND A-SMA by Aloka Co., Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2001
Date Received
May 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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  • 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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