IZF · Class II · 21 CFR 892.1740

FDA Product Code IZF: System, X-ray, Tomographic

Leading manufacturers include Siemens Corp., Nano-X Imaging , Ltd. and Toshiba Medical Systems.

42
Total
42
Cleared
85d
Avg days
1976
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 107d recently vs 83d historically

FDA 510(k) Cleared System, X-ray, Tomographic Devices (Product Code IZF)

42 devices
1–24 of 42
Cleared Feb 02, 2026
TAP2D
K252649
Nano-X Imaging , Ltd.
Radiology · 165d
Cleared Nov 06, 2025
Adaptix Ortho350
K252133
Adaptix Limited
Radiology · 122d
Cleared Apr 16, 2025
Nanox.ARC X
K250850
Nano-X Imaging , Ltd.
Radiology · 27d
Cleared Dec 04, 2024
Nanox.ARC
K242395
Nano-X Imaging , Ltd.
Radiology · 113d
Cleared Apr 28, 2023
Nanox.ARC
K222934
Nano-X Imaging , Ltd.
Radiology · 214d
Cleared Jan 26, 2023
Ortho Device, ADAPTIX 3D Orthopedic Imaging System
K221949
Pausch Medical GmbH
Radiology · 205d
Cleared Oct 26, 2021
CLISIS SYSTEMS, Discovery RF180
K213081
General Medical Merate S.P.A
Radiology · 33d
Cleared Mar 09, 2020
DR 600 with Tomosynthesis
K193262
Agfa N.V.
Radiology · 104d
Cleared Feb 01, 2019
DR 800 with Tomosynthesis
K183275
Agfa N.V.
Radiology · 70d
Cleared Nov 18, 2013
DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
K132261
Ge Medical Systems, LLC
Radiology · 122d
Cleared Nov 20, 2012
FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
K121499
Fujifilm Medical System U.S.A., Inc.
Radiology · 183d
Cleared Dec 09, 1994
TOMO-LINK
K944967
GE Medical Systems
Radiology · 59d
Cleared Dec 17, 1992
PHILIPS INTEGRIS H/HM SYSTEM
K925302
Philips Medical Systems, Inc.
Radiology · 57d
Cleared Jun 15, 1989
ORTHORALIX SD/ORTHORALIX SD CEPH
K890351
Philips Medical Systems North America, Inc.
Radiology · 142d
Cleared Sep 19, 1985
ORALIX PANORAMIC D.C.
K852768
Philips Medical Systems, Inc.
Radiology · 83d
Cleared Dec 29, 1983
DIGITILT LS-30 REMOTE CONTROL
K834288
Elscint, Inc.
Radiology · 31d
Cleared Jun 23, 1981
SOMATOM 2N
K811302
Siemens Corp.
Radiology · 43d
Cleared Mar 11, 1981
CLINIX-R TOMOGRAPHIC DEVICE
K810274
Philips Medical Systems (Cleveland), Inc.
Radiology · 37d
Cleared Mar 11, 1981
ZONOGRAPH 6
K810307
Siemens Corp.
Radiology · 34d
Cleared Dec 10, 1979
VTX (GE CATAOLG NO. B7005A)
K792067
General Electric Co.
Radiology · 56d
Cleared Apr 26, 1979
MULTIGRAPH
K790765
Siemens Corp.
Radiology · 7d
Cleared Sep 14, 1978
OPTIPLANIMAT
K781531
Siemens Corp.
Radiology · 8d
Cleared Mar 14, 1978
ORBITOME-UG
K780319
Philips Medical Systems (Cleveland), Inc.
Radiology · 18d
Cleared Aug 03, 1977
TUBE CONVEYOR MODEL DS-PB-4
K771296
Toshiba Medical Systems
Radiology · 55d

About Product Code IZF - Regulatory Context

510(k) Submission Activity

42 total 510(k) submissions under product code IZF since 1976, with 42 receiving FDA clearance (average review time: 85 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - IZF Product Code

Recent submissions under IZF have taken an average of 107 days to reach a decision - up from 83 days historically. Manufacturers should account for longer review timelines in current project planning.

IZF devices are reviewed by the Radiology panel. Browse all Radiology devices →