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510(k) K123681

1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL by Wipro GE Healthcare Private, Ltd. — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2013
Date Received
November 30, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coil, Magnetic Resonance, Specialty
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Wipro GE Healthcare Private, Ltd.

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  • K120168 — LULLABY LED PHOTTHERAPY SYSTEM (May 2, 2012)
  • K110556 — MINI TELEMETRY SYSTEM (July 19, 2011)
  • K102104 — GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (October 1, 2010)

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  • K244054 — 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247 (February 28, 2025)
  • K243675 — InkSpace Imaging Small Body Array (December 20, 2024)
  • K243316 — XENOVIEW 3.0T Chest Coil (November 19, 2024)
  • K242879 — dS Knee Coil 8ch 1.5T (October 18, 2024)
  • K243033 — dS Wrist coil 8ch 1.5T (October 18, 2024)