IZF — System, X-Ray, Tomographic Class II
FDA product code IZF covers "System, X-Ray, Tomographic", a Class II medical device regulated under 21 CFR 892.1740. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |