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510(k) K102748

31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T by Rapid Biomedical GmbH — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2011
Date Received
September 23, 2010
Clearance Type
Abbreviated
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 Rapid Biomedical GmbH

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  • K181948 — 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil (November 16, 2018)
  • K163661 — P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil (March 21, 2018)
  • K102348 — 31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H (December 22, 2010)
  • K083255 — 16CH AI BREAST COILS 1.5 T AND 3 T (November 21, 2008)

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  • K242879 — dS Knee Coil 8ch 1.5T (October 18, 2024)
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