Terarecon Inc

FDA Filings

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

FDA Registration(s)
Registration Number2954793
FEI Number3003243710
NameTERARECON, INC.
Owner & OperatorTERARECON, INC.
Contact Address4309 Emperor Blvd., Suite 310
Durham NC 27703 US
Official Correspondent
  • Patty O'Brien
  • x-919-3893120-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address39141 Civic Center Drive, Suite 240
Fremont, CA 94538 US
Establishment TypeManufacture Medical Device



Registration Number3014146081
FEI Number3014146081
NameTerarecon, Inc.
Owner & OperatorTERARECON, INC.
Contact Address4309 Emperor Blvd., Suite 310
Durham NC 27703 US
Official Correspondent
  • Patty O'Brien
  • x-919-3893120-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4309 Emperor Blvd., Suite 310
Durham, NC 27703 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
TeraRecon, Inc.
Neuro.Al Algorithm2020-11-06
TERARECON, INC.
iNtuition 2020-09-02
TERARECON, INC.
iNtuition 2020-09-02
TERARECON, INC.
iNtuition 2020-09-02
TERARECON, INC.
iNtuition 2020-09-02
TERARECON, INC.
iNtuition 2020-09-02
TERARECON, INC.
iNtuition 2020-09-02
TERARECON, INC.
iNtuition 2020-09-02
Terarecon, Inc.
Norstar AI Results Explorer2019-12-13
TERARECON, INC.
iNtuition-Structural Heart Module2019-09-24
TeraRecon Inc.
INtuition-Structural Heart Module2019-07-12
TERARECON, INC.
iNtuition-T1 Mapping and T2/T2* Mapping2018-10-24
TeraRecon Inc.,
INtuition-T1 Mapping And T2/T2* Mapping2018-09-24
TERARECON, INC.
AquariusAPS 2018-09-24
TERARECON, INC.
iNtuition-TDA, TVA, Parametric Mapping2014-01-13
TERARECON, INC.
INTUITION - TDA, TVA, PARAMETRIC MAPPING2013-12-24
TERARECON, INC.
iNtuition2013-12-02
TERARECON, INC.
INTUITION2013-04-02
TERARECON, INC.
AQUARIUS WORKSTATION2008-12-22
TERARECON, INC.
AQUARIUSNET Server2008-01-28
TERARECON, INC.
AQUARIUSAPS SERVER2006-05-15
TERARECON, INC.
AQUARIUSNET SERVER2001-09-13
TERARECON, INC.
AQUARIUS WORKSTATION2001-05-08
TERARECON, INC.
AQUARIUSAPS SERVER2001-01-25
Terarecon, Inc.
EnvoyAI2001-01-25
TERARECON, INC.
IIVS INTEGRATED IMAGE VIEWING STATION2000-05-26
TERARECON, INC.
RTR-2000/RTR-40001998-02-13

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