Indomitable Magnetic Resonance Imaging Scanner

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K002490 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• B3000/B3000M Magnetic Resonance Imaging Scanner

  Class II

  FDA 510(k) K883699 Active Cleared 31 Oct 1988

• Pinnacle Magnetic Resonance Imaging Scanner

  Class II

  FDA 510(k) K011485 Active Cleared 6 Jun 2001

• Ultimate 3000

  Class II

  FDA 510(k) K910839 Active Cleared 26 Jul 1991

• Quad 1200 Magnetic Resonance Imaging Scanner

  Class II

  FDA 510(k) K951681 Active Cleared 9 Nov 1995

• Indomitable Magnetic Resonance Imaging Scanner Accessory

  Class II

  FDA 510(k) K061930 Active Cleared 28 Jul 2006

• Magnetic Resonance Diagnostic Device(Accesory)

  Class II

  FDA 510(k) K915567 Active Cleared 15 May 1992

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