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
1011360573
Device Listing 1011360573
Listing Summary
#
Listing key
1011360573
Premarket submission
K231470
Device
Lunit INSIGHT DBT
Applicant
Lunit, Inc.
Product code
QDQ
Decision date
2023-11-06
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
300580
3021230777
3021230777
Dave Kim
1
N
2026-01-01
7505 Fannin St Ste 610 Houston TX US 77054