Product Code: IZF FDA class 2 21 CFR 892.1740

System, X-Ray, Tomographic

Radiology

A tomographic X-ray system produces cross-sectional images by moving the X-ray tube and image receptor in coordinated arcs, blurring out structures above and below the focal plane to provide enhanced detail of a specific tissue layer. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) clearance before marketing. The product code is IZF, regulated under 21 CFR 892.1740, within the Radiology medical specialty. This device is eligible for third-party review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code IZF in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: IZF
Device Class: FDA class 2
Regulation Number: 892.1740
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 42 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252649	TAP2D	Feb 02, 2026	Substantially Equivalent	Nano-X Imaging , Ltd.
K252133	Adaptix Ortho350	Nov 06, 2025	Substantially Equivalent	Adaptix Limited
K250850	Nanox.ARC X	Apr 16, 2025	Substantially Equivalent	Nano-X Imaging , Ltd.
K242395	Nanox.ARC	Dec 04, 2024	Substantially Equivalent	Nano-X Imaging , Ltd.
K222934	Nanox.ARC	Apr 28, 2023	Substantially Equivalent	Nano-X Imaging , Ltd.
K221949	Ortho Device, ADAPTIX 3D Orthopedic Imaging System	Jan 26, 2023	Substantially Equivalent	Pausch Medical GmbH
K213081	CLISIS SYSTEMS, Discovery RF180	Oct 26, 2021	Substantially Equivalent	General Medical Merate S.P.A
K193262	DR 600 with Tomosynthesis	Mar 09, 2020	Substantially Equivalent	Agfa N.V.
K183275	DR 800 with Tomosynthesis	Feb 01, 2019	Substantially Equivalent	Agfa N.V.
K132261	DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)	Nov 18, 2013	Substantially Equivalent	Ge Medical Systems, LLC
K121499	FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM	Nov 20, 2012	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K013620	MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION	Jan 22, 2002	Substantially Equivalent	Medstone Intl., Inc.
K011290	PROGNOST ES, MODEL 0302 0000	May 30, 2001	Substantially Equivalent	Xmar Corp.
K973864	COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO	Jun 17, 1998	Substantially Equivalent	Pausch Corp.
K973834	CS2000 & CS2000 TOMO	Apr 30, 1998	Substantially Equivalent	Pausch Corp.
K950571	LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270	Mar 31, 1995	Substantially Equivalent	Continental X-Ray Corp.
K945749	BENNETT X-RAY TOMOGRAPHY SYSTEM	Feb 15, 1995	Substantially Equivalent	Bennett X-Ray Corp.
K944967	TOMO-LINK	Dec 09, 1994	Substantially Equivalent	GE Medical Systems
K942175	LINEAR TOMOGRAPHIC SYSTEM: PMT 6000	Aug 17, 1994	Substantially Equivalent	Continental X-Ray Corp.
K931815	2000 X-RAY - TOMOGRAPHIC	Aug 23, 1993	Substantially Equivalent	Imaging Sciences Intl., Inc.
K924443	RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE	Feb 05, 1993	Substantially Equivalent	Control-X, Inc.
K925302	PHILIPS INTEGRIS H/HM SYSTEM	Dec 17, 1992	Substantially Equivalent	Philips Medical Systems, Inc.
K892653	TOMAX ULTRASCAN	Aug 28, 1989	Substantially Equivalent	Incubation Industries, Inc.
K890351	ORTHORALIX SD/ORTHORALIX SD CEPH	Jun 15, 1989	Substantially Equivalent	Philips Medical Systems North America, Inc.
K884650	RESUBMITTED SCANORA	Mar 16, 1989	Substantially Equivalent	Orion Corp.
K852768	ORALIX PANORAMIC D.C.	Sep 19, 1985	Substantially Equivalent	Philips Medical Systems, Inc.
K834288	DIGITILT LS-30 REMOTE CONTROL	Dec 29, 1983	Substantially Equivalent	Elscint, Inc.
K811302	SOMATOM 2N	Jun 23, 1981	Substantially Equivalent	Siemens Corp.
K811197	SUPERIX 120	Jun 09, 1981	Substantially Equivalent	Tecnomed, Inc.
K810307	ZONOGRAPH 6	Mar 11, 1981	Substantially Equivalent	Siemens Corp.
K810274	CLINIX-R TOMOGRAPHIC DEVICE	Mar 11, 1981	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K792327	INTEGRON	Dec 20, 1979	Substantially Equivalent	Tecnomed, Inc.
K792067	VTX (GE CATAOLG NO. B7005A)	Dec 10, 1979	Substantially Equivalent	General Electric Co.
K790765	MULTIGRAPH	Apr 26, 1979	Substantially Equivalent	Siemens Corp.
K790132	TECNOTOMO	Feb 21, 1979	Substantially Equivalent	Teknomed, Inc.
K781531	OPTIPLANIMAT	Sep 14, 1978	Substantially Equivalent	Siemens Corp.
K780995	COMPUTERIZED AXIAL TOMOGRAPHY	Jun 22, 1978	Substantially Equivalent	Emi Medical, Inc.
K780319	ORBITOME-UG	Mar 14, 1978	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K771549	VERSATOME	Aug 25, 1977	Substantially Equivalent	Kermath Mfg. Corp.
K771297	TUBESTAND MODEL DS-TA-4	Aug 03, 1977	Substantially Equivalent	Toshiba Medical Systems
K771296	TUBE CONVEYOR MODEL DS-PB-4	Aug 03, 1977	Substantially Equivalent	Toshiba Medical Systems
K761004	X-RAY SCANNER, WHOLE BODY, AS&E	Dec 16, 1976	Substantially Equivalent	American Science and Engineering, Inc.