Intelligent Retinal Imaging Systems, Inc. - Dec. 6, 2018
Issue Date
Dec 06, 2018
Region
Southeast
Category
Device
$117.00
Contact Name
Felicia Wynne
Contact Title
Vice President of Operations
Address 1
2 N. Palafox St.
Address 2
Ste. 200
City
Pensacola
State
FL
Zip/Postal Code
32502-4731
Country
United States
Inspection Range
Dec 04, 2018 - Dec 06, 2018
Pages
5
First Observation
Results of the validation of the device software were not adequately documented.
Investigator(s): Richard K. Vogel