IZF — System, X-Ray, Tomographic Class II
FDA Device Classification
Classification Details
- Product Code
- IZF
- Device Class
- Class II
- Regulation Number
- 892.1740
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252649 | nano-x imaging | TAP2D | February 2, 2026 |
| K252133 | adaptix limited | Adaptix Ortho350 | November 6, 2025 |
| K250850 | nano-x imaging | Nanox.ARC X | April 16, 2025 |
| K242395 | nano-x imaging | Nanox.ARC | December 4, 2024 |
| K222934 | nano-x imaging | Nanox.ARC | April 28, 2023 |
| K221949 | pausch medical | Ortho Device, ADAPTIX 3D Orthopedic Imaging System | January 26, 2023 |
| K213081 | general medical merate | CLISIS SYSTEMS, Discovery RF180 | October 26, 2021 |
| K193262 | agfa n.v | DR 600 with Tomosynthesis | March 9, 2020 |
| K183275 | agfa n.v | DR 800 with Tomosynthesis | February 1, 2019 |
| K132261 | ge medical systems | DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) | November 18, 2013 |
| K121499 | fujifilm medical system u.s.a | FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM | November 20, 2012 |
| K013620 | medstone intl | MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION | January 22, 2002 |
| K011290 | xmar | PROGNOST ES, MODEL 0302 0000 | May 30, 2001 |
| K973864 | pausch | COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO | June 17, 1998 |
| K973834 | pausch | CS2000 & CS2000 TOMO | April 30, 1998 |
| K950571 | continental x-ray | LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 | March 31, 1995 |
| K945749 | bennett x-ray | BENNETT X-RAY TOMOGRAPHY SYSTEM | February 15, 1995 |
| K944967 | ge medical systems | TOMO-LINK | December 9, 1994 |
| K942175 | continental x-ray | LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 | August 17, 1994 |
| K931815 | imaging sciences intl | 2000 X-RAY - TOMOGRAPHIC | August 23, 1993 |