System, X-Ray, Tomographic
Regulation 892.1740
2510(k)s in 12 months (42 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in IZF
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 2, 2026 | K252649 | TAP2D Nano-X Imaging , Ltd., IL | IZF |
| Nov 6, 2025 | K252133 | Adaptix Ortho350 Adaptix Limited, GB | IZF |
| Apr 16, 2025 | K250850 | Nanox.ARC X Nano-X Imaging , Ltd., IL | IZF |
| Dec 4, 2024 | K242395 | Nanox.ARC Nano-X Imaging , Ltd., IL | IZF |
| Apr 28, 2023 | K222934 | Nanox.ARC Nano-X Imaging , Ltd., IL | IZF |
| Jan 26, 2023 | K221949 | Ortho Device, ADAPTIX 3D Orthopedic Imaging System Pausch Medical GmbH, DE | IZF |
| Oct 26, 2021 | K213081 | CLISIS SYSTEMS, Discovery RF180 General Medical Merate S.P.A, IT | IZF |
| Mar 9, 2020 | K193262 | DR 600 with Tomosynthesis Agfa N.V., BE | IZF |
| Feb 1, 2019 | K183275 | DR 800 with Tomosynthesis Agfa N.V., BE | IZF |
| Nov 18, 2013 | K132261 | DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) Ge Medical Systems, LLC | IZF |
| Nov 20, 2012 | K121499 | FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM Fujifilm Medical System U.S.A., Inc. | IZF |
| Jan 22, 2002 | K013620 | MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION Medstone Intl., Inc. | IZF |
| May 30, 2001 | K011290 | PROGNOST ES, MODEL 0302 0000 Xmar Corp. | IZF |
| Jun 17, 1998 | K973864 | COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO Pausch Corp. | IZF |
| Apr 30, 1998 | K973834 | CS2000 & CS2000 TOMO Pausch Corp. | IZF |
| Mar 31, 1995 | K950571 | LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 Continental X-Ray Corp. | IZF |
| Feb 15, 1995 | K945749 | BENNETT X-RAY TOMOGRAPHY SYSTEM Bennett X-Ray Corp. | IZF |
| Dec 9, 1994 | K944967 | TOMO-LINK GE Medical Systems | IZF |
| Aug 17, 1994 | K942175 | LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 Continental X-Ray Corp. | IZF |
| Aug 23, 1993 | K931815 | 2000 X-RAY - TOMOGRAPHIC Imaging Sciences Intl., Inc. | IZF |
| Feb 5, 1993 | K924443 | RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE Control-X, Inc. | IZF |
| Dec 17, 1992 | K925302 | PHILIPS INTEGRIS H/HM SYSTEM Philips Medical Systems, Inc., NL | IZF |
| Aug 28, 1989 | K892653 | TOMAX ULTRASCAN Incubation Industries, Inc. | IZF |
| Jun 15, 1989 | K890351 | ORTHORALIX SD/ORTHORALIX SD CEPH Philips Medical Systems North America, Inc. | IZF |
| Mar 16, 1989 | K884650 | RESUBMITTED SCANORA Orion Corp., FI | IZF |
| Sep 19, 1985 | K852768 | ORALIX PANORAMIC D.C. Philips Medical Systems, Inc., NL | IZF |
| Dec 29, 1983 | K834288 | DIGITILT LS-30 REMOTE CONTROL Elscint, Inc. | IZF |
| Jun 23, 1981 | K811302 | SOMATOM 2N Siemens Corp. | IZF |
| Jun 9, 1981 | K811197 | SUPERIX 120 Tecnomed, Inc. | IZF |
| Mar 11, 1981 | K810307 | ZONOGRAPH 6 Siemens Corp. | IZF |
| Mar 11, 1981 | K810274 | CLINIX-R TOMOGRAPHIC DEVICE Philips Medical Systems (Cleveland), Inc. | IZF |
| Dec 20, 1979 | K792327 | INTEGRON Tecnomed, Inc. | IZF |
| Dec 10, 1979 | K792067 | VTX (GE CATAOLG NO. B7005A) General Electric Co. | IZF |
| Apr 26, 1979 | K790765 | MULTIGRAPH Siemens Corp. | IZF |
| Feb 21, 1979 | K790132 | TECNOTOMO Teknomed, Inc. | IZF |
| Sep 14, 1978 | K781531 | OPTIPLANIMAT Siemens Corp. | IZF |
| Jun 22, 1978 | K780995 | COMPUTERIZED AXIAL TOMOGRAPHY Emi Medical, Inc. | IZF |
| Mar 14, 1978 | K780319 | ORBITOME-UG Philips Medical Systems (Cleveland), Inc. | IZF |
| Aug 25, 1977 | K771549 | VERSATOME Kermath Mfg. Corp. | IZF |
| Aug 3, 1977 | K771297 | TUBESTAND MODEL DS-TA-4 Toshiba Medical Systems | IZF |
| Aug 3, 1977 | K771296 | TUBE CONVEYOR MODEL DS-PB-4 Toshiba Medical Systems | IZF |
| Dec 16, 1976 | K761004 | X-RAY SCANNER, WHOLE BODY, AS&E American Science and Engineering, Inc. | IZF |
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