FDA.reportPublic FDA data

SENSUS HEALTHCARE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30085133983008513398SENSUS HEALTHCARE1Y2026-01-01851 Broken Sound Pkwy. NW#215 Boca Raton FL US 33487

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1196391808342208K190255Sensus Healthcare TVM Balloon ApplicatorJAD2019-02-21
1196391669577565K182665Sensus TPS WorkstationMUJ2019-02-21
1196391458234559K182641Sensus IORT SystemJAD2019-02-21
1196391006551946K173425SRT-100+JAD2018-03-23
1196391161154081K150037Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging CapabilitiesJAD2015-10-16
1196391370812384K131582SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEMJAD2013-08-28
1196391737793414K123985SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100JAD2013-05-14
1196391476426840K063456SRT100 SUPERFICIAL RADIATION THERAPY SYSTEMJAD2007-01-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAD72019-02-21
MUJ12019-02-21

PMN#