FDA 510(k) Applications for Medical Device Product Code "IZF"
(System, X-Ray, Tomographic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K193262 | Agfa N.V. | DR 600 with Tomosynthesis | 03/09/2020 |
| K183275 | Agfa N.V. | DR 800 with Tomosynthesis | 02/01/2019 |
| K121499 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. | FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM | 11/20/2012 |
| K132261 | GE MEDICAL SYSTEMS, LLC | DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) | 11/18/2013 |
| K213081 | General Medical Merate S.P.A | CLISIS SYSTEMS, Discovery RF180 | 10/26/2021 |
| K013620 | MEDSTONE INTL., INC. | MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION | 01/22/2002 |
| K242395 | Nano-x Imaging Ltd. | Nanox.ARC | 12/04/2024 |
| K222934 | Nano-X Imaging Ltd. | Nanox.ARC | 04/28/2023 |
| K250850 | Nano-x Imaging Ltd. | Nanox.ARC X | 04/16/2025 |
| K973864 | PAUSCH CORP. | COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO | 06/17/1998 |
| K973834 | PAUSCH CORP. | CS2000 & CS2000 TOMO | 04/30/1998 |
| K221949 | Pausch Medical GmbH | Ortho Device, ADAPTIX 3D Orthopedic Imaging System | 01/26/2023 |
| K011290 | XMAR CORP. | PROGNOST ES, MODEL 0302 0000 | 05/30/2001 |
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