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.
| Registration Number | 9615832 |
| FEI Number | 3003026827 |
| Name | Noelle Zuccarello |
| Owner & Operator | OWANDY RADIOLOGY |
| Contact Address | 2 rue des vieilles vignes -- CROISSY-BEAUBOURG FR-NOTA 77183 FR |
| Official Correspondent |
|
| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 124 gaither drive suite 140 Mount Laurel, NJ 08054 US |
| Establishment Type | Repack or Relabel Medical Device |
Device Company | Device | Date |
|---|---|---|
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15615 | 2025-09-15 |
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15614 | 2025-09-15 |
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15613 | 2025-09-15 |
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15612 | 2025-09-15 |
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15611 | 2025-09-15 |
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15610 | 2025-09-15 |
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15690 | 2025-09-15 |
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15685 | 2025-09-15 |
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15609 | 2025-09-15 |
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15608 | 2025-09-15 |
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15607 | 2025-09-15 |
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15606 | 2025-09-15 |
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15604 | 2025-09-15 |
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15603 | 2025-09-15 |
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15602 | 2025-09-15 |
| OWANDY RADIOLOGY | Owandy-RX DC 5.92.15601 | 2025-09-12 |
| OWANDY RADIOLOGY | Owandy Radiology 9458100150 | 2025-05-23 |
| OWANDY RADIOLOGY | I-MAX 3D 9304100011.FL | 2024-11-19 |
| OWANDY RADIOLOGY | I-MAX 9304000011.FL | 2024-11-19 |
| OWANDY RADIOLOGY | Owandy Radiology 9304100011 | 2023-06-12 |
| OWANDY RADIOLOGY | Owandy Radiology 9304000011 | 2023-06-12 |
| OWANDY RADIOLOGY | Owandy Radiology 9458600200 | 2023-06-12 |
| OWANDY RADIOLOGY | Owandy Radiology 9458600100 | 2023-06-12 |
| OWANDY RADIOLOGY | Owandy Radiology 9458100200 | 2023-06-12 |
| OWANDY RADIOLOGY | Owandy Radiology 9458100100 | 2023-06-12 |
| 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 W0806091 | 2022-10-17 |
| OWANDY RADIOLOGY | Owandy-RX PRO W0806002 | 2022-10-17 |
| OWANDY RADIOLOGY | Owandy-RX PRO W0806001 | 2022-10-17 |
| OWANDY RADIOLOGY | Owandy-RX PRO W0806000 | 2022-10-17 |
| 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 9458900031 | 2020-02-28 |
| OWANDY RADIOLOGY | Owandy Radiology 9458900021 | 2020-02-28 |
Noelle Zuccarello [OWANDY RADIOLOGY] | I-MAX Touch 3D | 2019-12-19 |
Noelle Zuccarello [OWANDY RADIOLOGY] | I-MAX Touch | 2019-12-19 |
Noelle Zuccarello [OWANDY RADIOLOGY] | I-MAX Touch | 2019-12-19 |
Noelle Zuccarello [OWANDY RADIOLOGY] | Owandy-CR | 2019-06-17 |
Noelle Zuccarello [OWANDY RADIOLOGY] | NPR1000AA | 2019-06-17 |
Noelle Zuccarello [OWANDY RADIOLOGY] | I-MAX 3D | 2018-11-21 |
Noelle Zuccarello [OWANDY RADIOLOGY] | I-MAX | 2017-07-21 |
Noelle Zuccarello [OWANDY RADIOLOGY] | OwandyCam | 2015-10-05 |
Noelle Zuccarello [OWANDY RADIOLOGY] | Ow-RX | 2014-07-08 |
Noelle Zuccarello [OWANDY RADIOLOGY] | Opteo | 2014-05-27 |
Noelle Zuccarello [OWANDY RADIOLOGY] | ONE | 2014-05-27 |
Noelle Zuccarello [OWANDY RADIOLOGY] | ELIOS | 2007-12-20 |
Noelle Zuccarello [OWANDY RADIOLOGY] | ELIOS AC | 2007-12-20 |
| NCAGE Code | FBFS4 | OWANDY RADIOLOGY |
| CAGE Code | FBFS4 | OWANDY RADIOLOGY |