Medical Device Manufacturer · US , Minneapolis , MN

Surgical Information Sciences, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2017

Recent clearances: SIS System, SIS System, SIS System (Version 5.6.0)

7
Total
7
Cleared
0
Denied

FDA 510(k) Regulatory Record - Surgical Information Sciences, Inc. Radiology ✕

7 devices
1-7 of 7
Cleared Jun 14, 2024
SIS System
K241083 · QIH
Radiology · 56d
Cleared May 02, 2023
SIS System
K230977 · QIH
Radiology · 27d
Cleared Nov 21, 2022
SIS System (Version 5.6.0)
K223032 · QIH
Radiology · 53d
Cleared Mar 31, 2021
SIS System (Version 5.1.0)
K210071 · LLZ
Radiology · 79d
Cleared Sep 13, 2019
SIS Software Version 3.6.0
K192304 · LLZ
Radiology · 21d
Cleared CT Mar 19, 2019
SIS Software version 3.3.0
K183019 · LLZ
Radiology · 139d
Cleared Feb 14, 2017
SIS Software
K162830 · LLZ
Radiology · 130d
Filters
Filter by Specialty
All7 Radiology 7