NIO FUSION 4MP - Mdnc 4130

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

510(k) Number

K062905 ↗

FDA Product Code

LLZ

Models / Variants

Nio Fusion 4MP

Mdnc 4130

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Coronis 2MP and Mdcg 2121 - Cb

  Class II

  FDA 510(k) K061926 Active Cleared 18 Aug 2006

• Nio 2MP-20 and E-2620 S

  Class II

  FDA 510(k) K052276 Active Cleared 21 Sep 2005

• Mfcd 1219, Mfcd 1219 Ts

  Class II

  FDA 510(k) K052478 Active Cleared 28 Sep 2005

• Coronis 3MP and Mdcg 3120-Cb

  Class II

  FDA 510(k) K061924 Active Cleared 5 Sep 2006

• Color Nio 2MP, E-2320 C

  Class II

  FDA 510(k) K052958 Active Cleared 16 Nov 2005

• Coronis 2MP-21 and Mfgd 2621

  Class II

  FDA 510(k) K052403 Active Cleared 15 Sep 2005

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