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NRT X-RAY A/S

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
2
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1784-2024Class IIIntelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010April 17, 2024
Z-1669-2023Class IIIntelli-C, Left side suspended Tabletop, REF: 03400010April 27, 2023
Z-1668-2023Class IIIntelli-C, Right side suspended Tabletop, REF: 03400000April 27, 2023
Z-0526-2022Class II1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclJanuary 21, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K242948Adora DRFi (04550010)December 23, 2024
K173631Intelli-CJuly 11, 2018