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
1504428246
Device Listing 1504428246
Listing Summary
#
Listing key
1504428246
Premarket submission
K230807
Device
Deep Learning Image Reconstruction
Applicant
Ge Healthcare Japan Corporation
Product code
JAK
Decision date
2023-04-20
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
26607
2126677
2126677
GE MEDICAL SYSTEMS, LLC
1
Y
2026-01-01
3000 N GRANDVIEW BLVD. Waukesha WI US 53188
26605
9612283
3002808529
GE Healthcare Japan Corporation
1
N
2026-01-01
7-127, Asahigaoka 4-chome HINO-SHI Tokyo JP 191-8503