Cyber Medical Imaging, Inc. - Oct. 31, 2022
Issue Date
Oct 31, 2022
Region
Pacific
Category
Device
$117.00
Contact Name
Joel C. Karafin
Contact Title
Chief Operating Officer
Address 1
11300 W. Olympic Blvd.
Address 2
Ste. 710
City
Los Angeles
State
CA
Zip/Postal Code
90064-1643
Inspection Range
Oct 20, 2022 - Oct 31, 2022
Pages
3
First Observation
Changes to software used as pait of the quality system were not adequately validated before approval and issuance.
Investigator(s): Kelvin Cheung