Medical Device Manufacturer · IT , Imola (Bo)

Cefla S.C. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 2008

Recent clearances: Neowise, myray ProXIma X6, CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO

Official Website

21

Total

21

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cefla S.C. Radiology ✕

13 devices

1-12 of 13

Cleared May 04, 2026

Radiology · 60d

Cleared Mar 10, 2026

myray ProXIma X6

Radiology · 224d

Cleared Jan 17, 2023

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

Radiology · 29d

Cleared May 06, 2022

Radiology · 60d

Cleared Jan 20, 2022

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

Radiology · 24d

Cleared Apr 09, 2020

hyperion X5, NewTom GO, X-RADiUS COMPACT

Radiology · 24d

Cleared Apr 24, 2019

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

Radiology · 55d

Cleared Mar 08, 2019

Radiology · 86d

Cleared Jan 13, 2017

Radiology · 29d

Cleared Dec 09, 2016

Radiology · 151d

Cleared Dec 24, 2015

Myray- HYPERION X5

Radiology · 143d

Cleared May 10, 2013

Radiology · 190d