Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1017626099
Device Listing 1017626099
Listing Summary
#
Listing key
1017626099
Premarket submission
K153486
Device
Affirm Prone Biopsy System
Applicant
Hologic, Inc.
Product code
IZH
Decision date
2016-04-01
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
14120
1220984
1220984
Hologic, Inc.
1
N
2020-04-25
36 APPLE RIDGE RD. DANBURY CT US 06810
322332
3005496266
3005496266
HOLOGIC, INC.
1
N
2026-01-01
600 Technology Drive Newark DE US 19702