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510(k) K013150

MR-GUIDE 2000 by Ultraguide , Ltd. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2001
Date Received
September 20, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Ultraguide , Ltd.

  • K023227 — USG 2000SA (October 22, 2002)
  • K022354 — ULTRAGUIDE CTG 2000SA (August 13, 2002)
  • K011418 — ULTRAGUIDE MR-GUIDE 3000 (May 24, 2001)
  • K002258 — ULTRAGUIDE CT-GUIDE 1010 (August 8, 2000)
  • K974432 — ULTRAGUIDE 1000 (February 9, 1998)

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