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
1611970213
Device Listing 1611970213
Listing Summary
#
Listing key
1611970213
Premarket submission
K243446
Device
3DXR
Applicant
GE Medical Systems SCS
Product code
OWB
Decision date
2025-02-25
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
26609
9611343
1000284313
Tracey Holevas
1
N
2026-01-01
3000 N. Grandview BLVD Waukesha WI US 53188