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510(k) K133506

NORAS OR HEAD HOLDER FLEXIBILITY by Noras Mri Products GmbH — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2014
Date Received
November 14, 2013
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

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  • K093693 — NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 72 (January 19, 2010)
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  • K083578 — NORAS CPC MULTIFUNCTIONAL COIL (January 16, 2009)
  • K082373 — NORAS MR-BI320-PA 3T (August 29, 2008)
  • K081118 — NORAS MR-BI320-PA 1.5T (May 2, 2008)

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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)
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