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
1360665449
Device Listing 1360665449
Listing Summary
#
Listing key
1360665449
Premarket submission
K261331
Device
I-Genius (100019400)
Applicant
Esaote, S.p.A.
Product code
LNH
Decision date
2026-07-31
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
9838
1826555
1826555
Esaote North America, Inc
1
Y
2026-01-01
11907 Exit Five Parkway Fishers IN US 46037
9837
8043485
3002806926
Kim Akers
1
N
2026-01-01
11907 Exit 5 Pkwy Fishers IN US 46037