FDA 510(k), K961366, MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS

FDA 510(k), K961366, MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS

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510(K) Number: K961366
Device Name: MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS
Manufacturer: THOMAS SCHUBERT
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: LNH
Classification Product Code: KXA
Date Received: 04/09/1996
Decision Date: 07/03/1996
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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