Medical Device Manufacturer · BG , Varna

Smart Soft Healthcare AD - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2022
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Smart Soft Healthcare AD Radiology ✕
3 devices
1-3 of 3
Cleared Apr 01, 2026
CoLumbo C-Spine
K254015 · QIH
Radiology · 107d
Cleared May 28, 2025
CoLumboX
K250367 · QIH
Radiology · 107d
Cleared Jun 23, 2022
CoLumbo
K220497 · QIH
Radiology · 121d
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