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510(k) K072909

1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL by Siemens AG Medical Solutions — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2007
Date Received
October 12, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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  • K111079 — SYNGO.VIA WEB VIEWER (May 13, 2011)
  • K101666 — SYNGO. PLAZA VA20A (August 10, 2010)
  • K100637 — SYNGO.CT CORONARY ANALYSIS (May 26, 2010)
  • K093612 — SYNGO.PLAZA (March 4, 2010)
  • K092067 — ABVS WORKPLACE (September 18, 2009)
  • K092519 — SYNGO.X (August 27, 2009)

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  • K253182 — InkSpace Imaging Small Body Array (SBA12PH30x) (October 20, 2025)
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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)