Medical Device Manufacturer · US , Hasting On Hudson , NY

Nical Spa - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2006

Recent clearances: NICAL SMART MICRO CR system for intraoral dental images, NDR+/DIVA-D

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Nical Spa Radiology ✕

2 devices

1-2 of 2

Cleared Mar 18, 2015

NICAL SMART MICRO CR system for intraoral dental images

Radiology · 79d

Cleared Jan 06, 2006

Radiology · 71d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 21, 2026