Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K220039
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K220039
Device Name
System, Image Processing, Radiological
Applicant
AI Medic Inc.
2F, 437, Bongeunsa-ro, Gangnam-gu
Seoul KS013/06097 KR
Other 510(k) Applications for this Company
Contact
Jeong Soon Song
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/05/2022
Decision Date
07/20/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact