IZF · System, X-Ray, Tomographic
Radiology · 21 CFR 892.1740 · Class 2
Overview
| Product Code | IZF |
|---|---|
| Device Name | System, X-Ray, Tomographic |
| Regulation | 21 CFR 892.1740 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 42)
Showing 20 most recent of 42 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252649 | TAP2D | Nano-X Imaging , Ltd. | Feb 2, 2026 | SESE |
| K252133 | Adaptix Ortho350 | Adaptix Limited | Nov 6, 2025 | SESE |
| K250850 | Nanox.ARC X | Nano-X Imaging , Ltd. | Apr 16, 2025 | SESE |
| K242395 | Nanox.ARC | Nano-X Imaging , Ltd. | Dec 4, 2024 | SESE |
| K222934 | Nanox.ARC | Nano-X Imaging , Ltd. | Apr 28, 2023 | SESE |
| K221949 | Ortho Device, ADAPTIX 3D Orthopedic Imaging System | Pausch Medical GmbH | Jan 26, 2023 | SESE |
| K213081 | CLISIS SYSTEMS, Discovery RF180 | General Medical Merate S.P.A | Oct 26, 2021 | SESE |
| K193262 | DR 600 with Tomosynthesis | Agfa N.V. | Mar 9, 2020 | SESE |
| K183275 | DR 800 with Tomosynthesis | Agfa N.V. | Feb 1, 2019 | SESE |
| K132261 | DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) | Ge Medical Systems, LLC | Nov 18, 2013 | SESE |
| K121499 | FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM | Fujifilm Medical System U.S.A., Inc. | Nov 20, 2012 | SESE |
| K013620 | MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION | Medstone Intl., Inc. | Jan 22, 2002 | SESE |
| K011290 | PROGNOST ES, MODEL 0302 0000 | Xmar Corp. | May 30, 2001 | SESE |
| K973864 | COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO | Pausch Corp. | Jun 17, 1998 | SESE |
| K973834 | CS2000 & CS2000 TOMO | Pausch Corp. | Apr 30, 1998 | SESE |
| K950571 | LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 | Continental X-Ray Corp. | Mar 31, 1995 | SESE |
| K945749 | BENNETT X-RAY TOMOGRAPHY SYSTEM | Bennett X-Ray Corp. | Feb 15, 1995 | SESE |
| K944967 | TOMO-LINK | GE Medical Systems | Dec 9, 1994 | SESE |
| K942175 | LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 | Continental X-Ray Corp. | Aug 17, 1994 | SESE |
| K931815 | 2000 X-RAY - TOMOGRAPHIC | Imaging Sciences Intl., Inc. | Aug 23, 1993 | SESE |
Top Applicants
- Nano-X Imaging , Ltd. — 4 clearances
- Siemens Corp. — 4 clearances
- Agfa N.V. — 2 clearances
- Continental X-Ray Corp. — 2 clearances
- Pausch Corp. — 2 clearances
