Product code IZF
- Device name
- System, X-Ray, Tomographic
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1740
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252649 | TAP2D | Nano-X Imaging , Ltd. | 2026-02-02 |
| K252133 | Adaptix Ortho350 | Adaptix Limited | 2025-11-06 |
| K250850 | Nanox.ARC X | Nano-X Imaging , Ltd. | 2025-04-16 |
| K242395 | Nanox.ARC | Nano-X Imaging , Ltd. | 2024-12-04 |
| K222934 | Nanox.ARC | Nano-X Imaging , Ltd. | 2023-04-28 |
| K221949 | Ortho Device, ADAPTIX 3D Orthopedic Imaging System | Pausch Medical GmbH | 2023-01-26 |
| K213081 | CLISIS SYSTEMS, Discovery RF180 | General Medical Merate S.P.A | 2021-10-26 |
| K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020-03-09 |
| K183275 | DR 800 with Tomosynthesis | Agfa N.V. | 2019-02-01 |
| K132261 | DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) | Ge Medical Systems, LLC | 2013-11-18 |
| K121499 | FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM | Fujifilm Medical System U.S.A., Inc. | 2012-11-20 |
| K013620 | MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION | Medstone Intl., Inc. | 2002-01-22 |
| K011290 | PROGNOST ES, MODEL 0302 0000 | Xmar Corp. | 2001-05-30 |
| K973864 | COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO | Pausch Corp. | 1998-06-17 |
| K973834 | CS2000 & CS2000 TOMO | Pausch Corp. | 1998-04-30 |
| K950571 | LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 | Continental X-Ray Corp. | 1995-03-31 |
| K945749 | BENNETT X-RAY TOMOGRAPHY SYSTEM | Bennett X-Ray Corp. | 1995-02-15 |
| K944967 | TOMO-LINK | GE Medical Systems | 1994-12-09 |
| K942175 | LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 | Continental X-Ray Corp. | 1994-08-17 |
| K931815 | 2000 X-RAY - TOMOGRAPHIC | Imaging Sciences Intl., Inc. | 1993-08-23 |
| K924443 | RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE | Control-X, Inc. | 1993-02-05 |
| K925302 | PHILIPS INTEGRIS H/HM SYSTEM | Philips Medical Systems, Inc. | 1992-12-17 |
| K892653 | TOMAX ULTRASCAN | Incubation Industries, Inc. | 1989-08-28 |
| K890351 | ORTHORALIX SD/ORTHORALIX SD CEPH | Philips Medical Systems North America, Inc. | 1989-06-15 |
| K884650 | RESUBMITTED SCANORA | Orion Corp. | 1989-03-16 |
| K852768 | ORALIX PANORAMIC D.C. | Philips Medical Systems, Inc. | 1985-09-19 |
| K834288 | DIGITILT LS-30 REMOTE CONTROL | Elscint, Inc. | 1983-12-29 |
| K811302 | SOMATOM 2N | Siemens Corp. | 1981-06-23 |
| K811197 | SUPERIX 120 | Tecnomed, Inc. | 1981-06-09 |
| K810274 | CLINIX-R TOMOGRAPHIC DEVICE | Philips Medical Systems (Cleveland), Inc. | 1981-03-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07290018465066 | TAP2D | NANO-X IMAGING LTD | 2026-02-18 |
| 05061068070003 | Adaptix Ortho350 | ADAPTIX LIMITED | 2025-11-19 |
| 07290018465011 | Nanox.ARC X | NANO-X IMAGING LTD | 2025-09-04 |
| 04547410556438 | DR-ID 900MC | FUJIFILM CORPORATION | 2025-04-04 |
| 04547410556452 | DR-ID 900MC | FUJIFILM CORPORATION | 2025-04-04 |
| 07290018465004 | Nanox.ARC | NANO-X IMAGING LTD | 2023-10-26 |
| 00195278070265 | Definium | GE Hualun Medical Systems Co., Ltd | 2020-11-24 |
| 00195278118356 | Definium | GE Hualun Medical Systems Co., Ltd | 2020-11-24 |
| 00840682138598 | Discovery | GE Hualun Medical Systems Co., Ltd | 2018-11-05 |
| 08054890480055 | CLISIS SYSTEMS | GENERAL MEDICAL MERATE SPA | 2018-07-11 |
| 08054890480109 | Discovery RF180 | GENERAL MEDICAL MERATE SPA | 2018-07-11 |
| 04547410306651 | DR-ID 900MC | FUJIFILM CORPORATION | 2016-09-16 |
| 04547410307061 | DR-ID 900MC | FUJIFILM CORPORATION | 2016-09-16 |
| 00840682115322 | Discovery | GE Hualun Medical Systems Co., Ltd | 2016-05-26 |