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510(k) K011418

ULTRAGUIDE MR-GUIDE 3000 by Ultraguide , Ltd. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2001
Date Received
May 9, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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)
  • K013150 — MR-GUIDE 2000 (October 18, 2001)
  • K002258 — ULTRAGUIDE CT-GUIDE 1010 (August 8, 2000)
  • K974432 — ULTRAGUIDE 1000 (February 9, 1998)

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  • K251901 — Magnifico Open (100009900) (March 5, 2026)
  • K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/Q (February 23, 2026)
  • K260265 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (February 23, 2026)