Owandy Radiology

FDA Filings

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

FDA Registration(s)
Registration Number9615832
FEI Number3003026827
NameNoelle Zuccarello
Owner & OperatorOWANDY RADIOLOGY
Contact Address2 rue des vieilles vignes --
CROISSY-BEAUBOURG FR-NOTA 77183 FR
Official Correspondent
  • Eric - FAUVARQUE
  • 033-1-64111818-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address124 gaither drive suite 140
Mount Laurel, NJ 08054 US
Establishment TypeRepack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
OWANDY RADIOLOGY
I-MAX 3D 9304100011.FL2024-11-19
OWANDY RADIOLOGY
I-MAX 9304000011.FL2024-11-19
OWANDY RADIOLOGY
Owandy Radiology 93041000112023-06-12
OWANDY RADIOLOGY
Owandy Radiology 93040000112023-06-12
OWANDY RADIOLOGY
Owandy Radiology 94586002002023-06-12
OWANDY RADIOLOGY
Owandy Radiology 94586001002023-06-12
OWANDY RADIOLOGY
Owandy Radiology 94581002002023-06-12
OWANDY RADIOLOGY
Owandy Radiology 94581001002023-06-12
OWANDY RADIOLOGY
Owandy Radiology 2023-06-12
OWANDY RADIOLOGY
Owandy Radiology 2023-06-12
OWANDY RADIOLOGY
Owandy Radiology 2023-06-12
OWANDY RADIOLOGY
Owandy-RX PRO W08060912022-10-17
OWANDY RADIOLOGY
Owandy-RX PRO W08060022022-10-17
OWANDY RADIOLOGY
Owandy-RX PRO W08060012022-10-17
OWANDY RADIOLOGY
Owandy-RX PRO W08060002022-10-17
OWANDY RADIOLOGY
I-MAX 3D 2021-12-24
OWANDY RADIOLOGY
I-MAX 2021-12-24
OWANDY RADIOLOGY
I-MAX 2021-12-24
OWANDY RADIOLOGY
Owandy Radiology 94589000312020-02-28
OWANDY RADIOLOGY
Owandy Radiology 94589000212020-02-28
Noelle Zuccarello [OWANDY RADIOLOGY]
I-MAX Touch 3D2019-12-19
Noelle Zuccarello [OWANDY RADIOLOGY]
I-MAX Touch2019-12-19
Noelle Zuccarello [OWANDY RADIOLOGY]
I-MAX Touch2019-12-19
Noelle Zuccarello [OWANDY RADIOLOGY]
Owandy-CR2019-06-17
Noelle Zuccarello [OWANDY RADIOLOGY]
NPR1000AA2019-06-17
Noelle Zuccarello [OWANDY RADIOLOGY]
I-MAX 3D2018-11-21
Noelle Zuccarello [OWANDY RADIOLOGY]
I-MAX2017-07-21
Noelle Zuccarello [OWANDY RADIOLOGY]
OwandyCam2015-10-05
Noelle Zuccarello [OWANDY RADIOLOGY]
Ow-RX2014-07-08
Noelle Zuccarello [OWANDY RADIOLOGY]
Opteo2014-05-27
Noelle Zuccarello [OWANDY RADIOLOGY]
ONE2014-05-27
Noelle Zuccarello [OWANDY RADIOLOGY]
ELIOS2007-12-20
Noelle Zuccarello [OWANDY RADIOLOGY]
ELIOS AC2007-12-20

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