Cefla S.C. - FDA 510(k) Cleared Devices
20
Total
20
Cleared
0
Denied
FDA 510(k) cleared devices by Cefla S.C. Radiology ✕
12 devices
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
NewTom 7G
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
NewTom 5G XL
Radiology
86d
Cleared
Jan 13, 2017
RX DC
Radiology
29d
Cleared
Dec 09, 2016
HYPERION X5
Radiology
151d
Cleared
Dec 24, 2015
Myray- HYPERION X5
Radiology
143d
Cleared
May 10, 2013
HYPERION X9
Radiology
190d
Cleared
Nov 06, 2008
MYRAY SKYVIEW
Radiology
204d