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
1626526641
Device Listing 1626526641
Listing Summary
#
Listing key
1626526641
Premarket submission
K253836
Device
FCT iStream Phase 2
Applicant
Fujifilm Corporation
Product code
JAK
Decision date
2026-09-04
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
291593
3018423337
3018423337
Randy Vader
1
N
2026-01-01
81 Hartwell Ave Ste 100 Lexington MA US 02421
330648
3032109225
3032109225
FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office
1
N
2026-01-01
2-1, Shintoyofuta Kashiwa-shi Chiba JP 277-0804