FDA Product Code
FDA Product Code IZF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1740
510(k) Clearances — 42 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252649 | TAP2D | Nano-X Imaging , Ltd. | 2026-02-02 | Traditional | PDF ↗ |
| K252133 | Adaptix Ortho350 | Adaptix Limited | 2025-11-06 | Traditional | PDF ↗ |
| K250850 | Nanox.ARC X | Nano-X Imaging , Ltd. | 2025-04-16 | Traditional | PDF ↗ |
| K242395 | Nanox.ARC | Nano-X Imaging , Ltd. | 2024-12-04 | Traditional | PDF ↗ |
| K222934 | Nanox.ARC | Nano-X Imaging , Ltd. | 2023-04-28 | Traditional | PDF ↗ |
| K221949 | Ortho Device, ADAPTIX 3D Orthopedic Imaging System | Pausch Medical GmbH | 2023-01-26 | Traditional | PDF ↗ |
| K213081 | CLISIS SYSTEMS, Discovery RF180 | General Medical Merate S.P.A | 2021-10-26 | Traditional | PDF ↗ |
| K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020-03-09 | Traditional | PDF ↗ |
| K183275 | DR 800 with Tomosynthesis | Agfa N.V. | 2019-02-01 | Traditional | PDF ↗ |
| K132261 | DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) | Ge Medical Systems, LLC | 2013-11-18 | Traditional | PDF ↗ |
| K121499 | FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM | Fujifilm Medical System U.S.A., Inc. | 2012-11-20 | Traditional | PDF ↗ |
| K013620 | MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION | Medstone Intl., Inc. | 2002-01-22 | Traditional | PDF ↗ |
| K011290 | PROGNOST ES, MODEL 0302 0000 | Xmar Corp. | 2001-05-30 | Traditional | PDF ↗ |
| K973864 | COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO | Pausch Corp. | 1998-06-17 | Traditional | PDF ↗ |
| K973834 | CS2000 & CS2000 TOMO | Pausch Corp. | 1998-04-30 | Traditional | PDF ↗ |
| K950571 | LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 | Continental X-Ray Corp. | 1995-03-31 | Traditional | PDF ↗ |
| K945749 | BENNETT X-RAY TOMOGRAPHY SYSTEM | Bennett X-Ray Corp. | 1995-02-15 | Traditional | PDF ↗ |
| K944967 | TOMO-LINK | GE Medical Systems | 1994-12-09 | Traditional | PDF ↗ |
| K942175 | LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 | Continental X-Ray Corp. | 1994-08-17 | Traditional | PDF ↗ |
| K931815 | 2000 X-RAY - TOMOGRAPHIC | Imaging Sciences Intl., Inc. | 1993-08-23 | Traditional | PDF ↗ |
| K924443 | RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE | Control-X, Inc. | 1993-02-05 | Traditional | PDF ↗ |
| K925302 | PHILIPS INTEGRIS H/HM SYSTEM | Philips Medical Systems, Inc. | 1992-12-17 | Traditional | PDF ↗ |
| K892653 | TOMAX ULTRASCAN | Incubation Industries, Inc. | 1989-08-28 | Traditional | PDF ↗ |
| K890351 | ORTHORALIX SD/ORTHORALIX SD CEPH | Philips Medical Systems North America, Inc. | 1989-06-15 | Traditional | PDF ↗ |
| K884650 | RESUBMITTED SCANORA | Orion Corp. | 1989-03-16 | Traditional | PDF ↗ |
| K852768 | ORALIX PANORAMIC D.C. | Philips Medical Systems, Inc. | 1985-09-19 | Traditional | PDF ↗ |
| K834288 | DIGITILT LS-30 REMOTE CONTROL | Elscint, Inc. | 1983-12-29 | Traditional | PDF ↗ |
| K811302 | SOMATOM 2N | Siemens Corp. | 1981-06-23 | Traditional | PDF ↗ |
| K811197 | SUPERIX 120 | Tecnomed, Inc. | 1981-06-09 | Traditional | PDF ↗ |
| K810307 | ZONOGRAPH 6 | Siemens Corp. | 1981-03-11 | Traditional | PDF ↗ |
| K810274 | CLINIX-R TOMOGRAPHIC DEVICE | Philips Medical Systems (Cleveland), Inc. | 1981-03-11 | Traditional | PDF ↗ |
| K792327 | INTEGRON | Tecnomed, Inc. | 1979-12-20 | Traditional | PDF ↗ |
| K792067 | VTX (GE CATAOLG NO. B7005A) | General Electric Co. | 1979-12-10 | Traditional | PDF ↗ |
| K790765 | MULTIGRAPH | Siemens Corp. | 1979-04-26 | Traditional | PDF ↗ |
| K790132 | TECNOTOMO | Teknomed, Inc. | 1979-02-21 | Traditional | PDF ↗ |
| K781531 | OPTIPLANIMAT | Siemens Corp. | 1978-09-14 | Traditional | PDF ↗ |
| K780995 | COMPUTERIZED AXIAL TOMOGRAPHY | Emi Medical, Inc. | 1978-06-22 | Traditional | PDF ↗ |
| K780319 | ORBITOME-UG | Philips Medical Systems (Cleveland), Inc. | 1978-03-14 | Traditional | PDF ↗ |
| K771549 | VERSATOME | Kermath Mfg. Corp. | 1977-08-25 | Traditional | PDF ↗ |
| K771296 | TUBE CONVEYOR MODEL DS-PB-4 | Toshiba Medical Systems | 1977-08-03 | Traditional | PDF ↗ |
| K771297 | TUBESTAND MODEL DS-TA-4 | Toshiba Medical Systems | 1977-08-03 | Traditional | PDF ↗ |
| K761004 | X-RAY SCANNER, WHOLE BODY, AS&E | American Science and Engineering, Inc. | 1976-12-16 | Traditional | PDF ↗ |
Product code IZF · Class II · Radiology. Data: openFDA.