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
1611158319
Device Listing 1611158319
Listing Summary
#
Listing key
1611158319
Premarket submission
K173789
Device
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
Applicant
Elekta Instrument AB
Product code
IWB
Decision date
2018-03-30
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
95802
9612186
3002806883
Elekta Instrument AB
1
N
2026-01-01
Hagaplan 4 Stockholm SE 11368
228750
3015232217
3015232217
ELEKTA SOLUTIONS AB
1
N
2026-01-01
Hagaplan 4 STOCKHOLM SE 11368