Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K211215
Device Classification Name
Full Field Digital,System,X-Ray,Mammographic
More FDA Info for this Device
510(K) Number
K211215
Device Name
Full Field Digital,System,X-Ray,Mammographic
Applicant
GE Healthcare
283 Rue de la MiniΦre
Buc 78530 FR
Other 510(k) Applications for this Company
Contact
Florian Akpakpa
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MUE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/23/2021
Decision Date
06/22/2021
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