Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K221305
Device Classification Name
More FDA Info for this Device
510(K) Number
K221305
Device Name
AI-Rad Companion Organs RT
Applicant
Siemens Medical Solutions USA, Inc
40 Liberty Blvd. Mail Code 65-3
Malvern, PA 19355 US
Other 510(k) Applications for this Company
Contact
Kira Kuzmenchuk
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QKB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/05/2022
Decision Date
10/14/2022
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