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System, X-Ray, Tomographic

FDA product code IZF · 42 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1740
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-12-16 – 2026-02-02

IZF 2026-02-02

TAP2D

Applicant Nano-X Imaging , Ltd.

K number K252649

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IZF 2025-11-06

Adaptix Ortho350

Applicant Adaptix Limited

K number K252133

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IZF 2025-04-16

Nanox.ARC X

Applicant Nano-X Imaging , Ltd.

K number K250850

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IZF 2024-12-04

Nanox.ARC

Applicant Nano-X Imaging , Ltd.

K number K242395

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IZF 2023-04-28

Nanox.ARC

Applicant Nano-X Imaging , Ltd.

K number K222934

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IZF 2023-01-26

Ortho Device, ADAPTIX 3D Orthopedic Imaging System

Applicant Pausch Medical GmbH

K number K221949

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IZF 2021-10-26

CLISIS SYSTEMS, Discovery RF180

Applicant General Medical Merate S.P.A

K number K213081

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IZF 2020-03-09

DR 600 with Tomosynthesis

Applicant Agfa N.V.

K number K193262

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IZF 2019-02-01

DR 800 with Tomosynthesis

Applicant Agfa N.V.

K number K183275

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IZF 2013-11-18

DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)

Applicant Ge Medical Systems, LLC

K number K132261

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IZF 2012-11-20

FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM

Applicant Fujifilm Medical System U.S.A., Inc.

K number K121499

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IZF 2002-01-22

MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION

Applicant Medstone Intl., Inc.

K number K013620

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IZF 2001-05-30

PROGNOST ES, MODEL 0302 0000

Applicant Xmar Corp.

K number K011290

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IZF 1998-06-17

COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO

Applicant Pausch Corp.

K number K973864

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IZF 1998-04-30

CS2000 & CS2000 TOMO

Applicant Pausch Corp.

K number K973834

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IZF 1995-03-31

LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270

Applicant Continental X-Ray Corp.

K number K950571

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IZF 1995-02-15

BENNETT X-RAY TOMOGRAPHY SYSTEM

Applicant Bennett X-Ray Corp.

K number K945749

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IZF 1994-12-09

TOMO-LINK

Applicant GE Medical Systems

K number K944967

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IZF 1994-08-17

LINEAR TOMOGRAPHIC SYSTEM: PMT 6000

Applicant Continental X-Ray Corp.

K number K942175

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IZF 1993-08-23

2000 X-RAY - TOMOGRAPHIC

Applicant Imaging Sciences Intl., Inc.

K number K931815

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IZF 1993-02-05

RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE

Applicant Control-X, Inc.

K number K924443

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IZF 1992-12-17

PHILIPS INTEGRIS H/HM SYSTEM

Applicant Philips Medical Systems, Inc.

K number K925302

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IZF 1989-08-28

TOMAX ULTRASCAN

Applicant Incubation Industries, Inc.

K number K892653

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IZF 1989-06-15

ORTHORALIX SD/ORTHORALIX SD CEPH

Applicant Philips Medical Systems North America, Inc.

K number K890351

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IZF 1989-03-16

RESUBMITTED SCANORA

Applicant Orion Corp.

K number K884650

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IZF 1985-09-19

ORALIX PANORAMIC D.C.

Applicant Philips Medical Systems, Inc.

K number K852768

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IZF 1983-12-29

DIGITILT LS-30 REMOTE CONTROL

Applicant Elscint, Inc.

K number K834288

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IZF 1981-06-23

SOMATOM 2N

Applicant Siemens Corp.

K number K811302

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IZF 1981-06-09

SUPERIX 120

Applicant Tecnomed, Inc.

K number K811197

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IZF 1981-03-11

ZONOGRAPH 6

Applicant Siemens Corp.

K number K810307

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IZF 1981-03-11

CLINIX-R TOMOGRAPHIC DEVICE

Applicant Philips Medical Systems (Cleveland), Inc.

K number K810274

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IZF 1979-12-20

INTEGRON

Applicant Tecnomed, Inc.

K number K792327

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IZF 1979-12-10

VTX (GE CATAOLG NO. B7005A)

Applicant General Electric Co.

K number K792067

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IZF 1979-04-26

MULTIGRAPH

Applicant Siemens Corp.

K number K790765

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IZF 1979-02-21

TECNOTOMO

Applicant Teknomed, Inc.

K number K790132

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IZF 1978-09-14

OPTIPLANIMAT

Applicant Siemens Corp.

K number K781531

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IZF 1978-06-22

COMPUTERIZED AXIAL TOMOGRAPHY

Applicant Emi Medical, Inc.

K number K780995

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IZF 1978-03-14

ORBITOME-UG

Applicant Philips Medical Systems (Cleveland), Inc.

K number K780319

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IZF 1977-08-25

VERSATOME

Applicant Kermath Mfg. Corp.

K number K771549

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IZF 1977-08-03

TUBESTAND MODEL DS-TA-4

Applicant Toshiba Medical Systems

K number K771297

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IZF 1977-08-03

TUBE CONVEYOR MODEL DS-PB-4

Applicant Toshiba Medical Systems

K number K771296

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IZF 1976-12-16

X-RAY SCANNER, WHOLE BODY, AS&E

Applicant American Science and Engineering, Inc.

K number K761004

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