Radiology Medical Diagnostic X-Ray Equipment
Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]
| Radiation Type | Ionizing |
| Radition Safety | Product |
| Annual Reports | Yes |
| 5339 | System, X-ray, Tomographic | Tomographic X-ray System. |
| 5339 | System, X-ray, Tomographic | Tomographic X-ray System. |
| K213081 | CLISIS SYSTEMS, Discovery RF180 | General Medical Merate S.P.A |
| K193262 | DR 600 With Tomosynthesis | Agfa N.V. |
| K183275 | DR 800 With Tomosynthesis | Agfa N.V. |
| K132261 | DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) | GE MEDICAL SYSTEMS, LLC |
| K121499 | FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM | FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K013620 | MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION | MEDSTONE INTL., INC. |
| K011290 | PROGNOST ES, MODEL 0302 0000 | XMAR CORP. |
| K973864 | COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO | PAUSCH CORP. |
| K973834 | CS2000 & CS2000 TOMO | PAUSCH CORP. |
| K950571 | LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 | CONTINENTAL X-RAY CORP. |
| K945749 | BENNETT X-RAY TOMOGRAPHY SYSTEM | BENNETT X-RAY CORP. |
| K944967 | TOMO-LINK | GE MEDICAL SYSTEMS |
| K942175 | LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 | CONTINENTAL X-RAY CORP. |
| K931815 | 2000 X-RAY - TOMOGRAPHIC | IMAGING SCIENCES INTL., INC. |
| K925302 | PHILIPS INTEGRIS H/HM SYSTEM | PHILIPS MEDICAL SYSTEMS, INC. |
| 00840682115322 | System, x-ray, tomographic |
| 07290018465004 | System, X-Ray, Tomographic |
| DISCOVERY XR656 | GE HANGWEI MEDICAL SYSTEMS CO., LTD. | 2015-06-26 |
| PHILIPS INTEGRIS H | PHILIPS | 2014-12-30 |
| DEFINIUM 8000 | GE MEDICAL SYSTEM, LLC | 2013-03-01 |
| GESYSTEM, X-RAY, TOMOGRAPHIC | GE HEALTHCARE | 2012-09-17 |
| CLINIXE SYSTEM | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | 2012-08-01 |
| DEFINIUM 8000 | GE MEDICAL SYSTEMS, LLC | 2012-01-18 |
| CESAR-OMCP-VISUB (HM3000) | PHILIPS HEALTHCARE | 2011-08-16 |
| POLY C-OMCP-VISUB (H3000) | PHILIPS HEALTHCARE | 2011-08-04 |
| PLY C-OMCP-VISUB (H3000) | PHILIPS HEALTHCARE | 2011-08-04 |
| POLY-C-OMCP-VISUB (H3000) | PHILIPS HEALTHCARE | 2011-05-20 |
| POLY C-LARC-OMCP-VISUB (BH3000) | PHILIPS HEALTHCARE | 2011-05-16 |
| CESAR-OMCP-VISUB (HM3000) | PHILIPS HEALTHCARE | 2011-05-05 |
| DISCOVERY XR650 | GE MEDICAL SYSTEMS, LLC | 2011-05-02 |
| CESAR-OMCP-VISUB (HM3000) | PHILIPS HEALTHCARE | 2011-04-12 |
| DISCOVERY XR650 | GE MEDICAL SYSTEMS, LLC | 2011-03-31 |
| POLY C-OMCP-VISUB (H3000) | PHILIPS HEALTHCARE | 2011-03-16 |
| POLY C-LARC-OMCP-VISUB (BH3000) | PHILIPS HEALTHCARE | 2011-03-14 |
| POLY C-OMCP-VISUB (H3000) | PHILIPS HEALTHCARE | 2011-03-14 |
| CESAR-OMCP-VISUB (HM3000) | PHILIPS HEALTHCARE | 2011-03-11 |
| CESAR-OMCP-VISUB (HM3000) | PHILIPS HEALTHCARE | 2011-03-02 |
| CESAR-OMCP-VISUB (HM3000) | PHILIPS HEALTHCARE | 2011-03-01 |
| POLY C-OMCP-VISUB (H3000) | PHILIPS HEALTHCARE | 2011-02-23 |
| POLY-C-OMCP-VISUB(H3000) | PHILIPS HEALTHCARE | 2011-02-10 |
| POLY C-OMCP-VISUB | PHILIPS HEALTHCARE | 2011-02-08 |
| CESAR-OMCP-VISUB (HM3000) | PHILIPS HEALTHCARE | 2011-02-02 |
| CESAR-OMCP-VISUB (HM3000) | PHILIPS HEALTHCARE | 2011-01-31 |
| CESAR-OMCP-VISUB (HM3000) | PHILIPS HEALTHCARE | 2011-01-28 |
| POLY C-OMCP-VISUB (H3000) | PHILIPS HEALTHCARE | 2011-01-25 |
| CESAR-OMCP-VISUB (HM3000) | PHILIPS HEALTHCARE | 2011-01-18 |
| CESAR-OMCP-VISUB (HM3000) | PHILIPS HEALTHCARE | 2011-01-14 |
| INTEGRIS H3000 | PHILIPS MEDICAL SYSTEMS | 2010-12-28 |
| INTEGRIS HM3000 | PHILIPS MEDICAL SYSTEMS | 2010-12-08 |
| INTEGRIS HM3000 | PHILIPS MEDICAL SYSTEMS | 2010-11-29 |
| INTEGRIS H3000 | PHILIPS MEDICAL SYSTEMS | 2010-11-17 |
| INTEGRIS H/HM (HM3000) SYSTEM | PHILIPS MEDICAL SYSTEMS | 2010-10-20 |
| INTEGRIS HM3000 | PHILIPS MEDICAL SYSTEMS | 2010-09-29 |
| TOMOTHERAPY | TOMOTHERAPY INCORPORATED | 2008-08-15 |
| DEFINLUM 8000 | GE HANGWEI MEDICAL SYSTEMS CO., LTD. | 2007-11-07 |
| TOSHIBA | TOSHIBA MEDICAL CO. | 2001-02-02 |
| TREX PMT 6600 | TREX MEDICAL CORP. XRE DIV. | 2000-05-24 |
| ** | NUCLETRON BV | 1998-11-11 |
| VERIFLEX | NUCLETRON BV | 1998-04-02 |