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510(k) K011604

PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI by Ge Medical Systems, Inc. — Product Code LNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2001
Date Received
May 24, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Spectroscopic
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

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Other clearances for product code LNI

  • K093044 — OASIS MRI SYSTEM (March 16, 2010)
  • K071506 — ECHELON SPECTROSCOPY PACKAGE (June 28, 2007)
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  • K003575 — MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM (January 17, 2001)
  • K991568 — MR SPECTROSCOPY PACKAGE (July 19, 1999)
  • K984167 — SAGE 7 (January 12, 1999)
  • K962627 — CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM (April 3, 1997)
  • K970005 — GYREX 2T-PRESTIGE (March 28, 1997)
  • K930265 — HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT (April 25, 1995)