Scandidos Ab

FDA Filings

This page includes the latest FDA filings for Scandidos Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005596716
FEI Number3005596716
NameJeff Spielman
Owner & OperatorSCANDIDOS AB
Contact AddressUPPSALA SCIENCE PARK 52A --
UPPSALA SE-C Uppsala lan [SE-03] SE-751 83 SE
Official Correspondent
  • Rajeshwari - Marikkannu
  • 46-76-5832879-0
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5520 NOBEL DR STE 150
FITCHBURG, WI 53711 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Scandidos AB
 Delta4 Phantom+ MR SDOS101-342019-05-02
Scandidos AB
 Delta4 Phantom+ MR SDOS101-362019-05-02
Scandidos AB
 Delta4 Phantom+ SDOS101-212019-04-24
Scandidos AB
 Delta4 Phantom+ SDOS101-202019-04-24
Jeff Spielman [SCANDIDOS AB]
Delta4 Phantom+ MR2019-04-23
ScandiDos AB
Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)2019-04-08
Scandidos AB
 Delta4 Discover SDOS105-022018-07-06
Scandidos AB
 Delta4 Discover SDOS105-01 (Varian)2018-07-06
Scandidos AB
 HexaMotion SDOS104-052018-03-29
Scandidos AB
 Delta4 Phantom+ SDOS101-302018-03-29
Scandidos AB
 Delta4 Phantom+ SDOS101-352018-03-29
Jeff Spielman [SCANDIDOS AB]
Delta4 Discover2016-02-03
SCANDIDOS AB
ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+2016-01-29
SCANDIDOS AB
ScandiDos Delta4 Phantom+2015-08-19
Jeff Spielman [SCANDIDOS AB]
Hexamotion2011-05-26
Jeff Spielman [SCANDIDOS AB]
Delta4PT2007-10-08
SCANDIDOS AB
DELTA42006-01-12

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