Model 545g-64 Pahased Array Musculoskeletal Flex Coil Package Model 543GE-64: Phased Array Upper Extrenity Flex Coil Any

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K983109 ↗

FDA Product Code

MOS

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Phased Array Shoulder Coil, Quadrature Shoulder Coil

  Class II

  FDA 510(k) K945778 Active Cleared 23 Mar 1995

• Multi Purpose Flex Array Coil : Model 235 Series

  Class II

  FDA 510(k) K000345 Active Cleared 11 Apr 2000

• Model 475 - 8 Channel T/R Phased Array Lower Extremity Coil

  Class II

  FDA 510(k) K040640 Active Cleared 22 Mar 2004

• Model 600GE-64: Bilateral Breast Coil

  Class II

  FDA 510(k) K930122 Active Cleared 26 Jul 1993

• Model 455GE Phased Array Wrist Coil

  Class II

  FDA 510(k) K010074 Active Cleared 3 Apr 2001

• Magnetic Resonance Diagnostic Accessory

  Class II

  FDA 510(k) K940364 Active Cleared 21 Jun 1994

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