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 |
| 5345 | Generator, High-voltage, X-ray, Diagnostic | Diagnostic X-ray High Voltage Generator. |
| 5345 | Generator, High-voltage, X-ray, Diagnostic | Diagnostic X-ray High Voltage Generator. |
| Generator, High-Voltage, X-Ray, Diagnostic [37593] | 21 CFR §892.1700 🔎 |
| Generator, High-Voltage, X-Ray, Diagnostic [37630] | 21 CFR §892.1700 🔎 |
| Generator, High-Voltage, X-Ray, Diagnostic [33118] | 21 CFR §892.1700 🔎 |
| Generator, High-Voltage, X-Ray, Diagnostic [32777] | 21 CFR §892.1700 🔎 |
| K953831 | N 800 HF | NUCLETRON-OLDELFT CORP. |
| K952822 | SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G | SHIMADZU CORP. |
| K952265 | MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR | CONTROL-X, INC. |
| K950883 | POLYDOROS SX 65 AND 80 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K950694 | COMPACT-X | ELECTROMED INTL., LTD. |
| K950291 | DIGITAL 625HF | FISCHER IMAGING CORP. |
| K950041 | SII 360 APR | SCOTT IMAGING INTL., INC. |
| K950040 | SII 525 APR | SCOTT IMAGING INTL., INC. |
| K950037 | N 800 HF | OLDELFT CORP. OF AMERICA |
| K945731 | HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS | BENNETT X-RAY CORP. |
| K945668 | KXO-80G | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K945452 | UD 150L-F | SHIMADZU MEDICAL SYSTEMS |
| K945453 | UD 150L-R II | SHIMADZU MEDICAL SYSTEMS |
| K944148 | MICRO X-30HF | FISCHER IMAGING CORP. |
| K944147 | MICRO X-50 HF | FISCHER IMAGING CORP. |
| 00884838088559 | Generator, high-voltage, x-ray, diagnostic |
| 00884838088542 | Generator, high-voltage, x-ray, diagnostic |
| 00884838086975 | Generator, high-voltage, x-ray, diagnostic |
| 00884838084520 | Generator, high-voltage, x-ray, diagnostic |
| 00884838076150 | Generator, high-voltage, x-ray, diagnostic |
| 00884838076143 | Generator, high-voltage, x-ray, diagnostic |
| 00884838076136 | Generator, high-voltage, x-ray, diagnostic |
| 00884838076129 | Generator, high-voltage, x-ray, diagnostic |
| 00884838075931 | Generator, high-voltage, x-ray, diagnostic |
| 00884838070851 | Generator, high-voltage, x-ray, diagnostic |
| 04540217052134 | Generator, High-Voltage, X-Ray, Diagnostic |
| 04540217052127 | Generator, High-Voltage, X-Ray, Diagnostic |
| 04540217052110 | Generator, High-Voltage, X-Ray, Diagnostic |
| 04540217052103 | Generator, High-Voltage, X-Ray, Diagnostic |
| 04540217052097 | Generator, High-Voltage, X-Ray, Diagnostic |
| 2020-03-10 | ||
| 2020-03-10 | ||
| 2020-02-19 | ||
| GENERATOR, HIGH-VOLTAGE, X-RAY, DIAGNOSTIC | COMMUNICATIONS & POWER INDUSTRIES CANADA, INC | 2019-06-18 |
| ANTHEM GENERATOR | DEL MEDICAL INC. | 2019-04-15 |
| GE DIGITAL ENERGY | GE CONSUMER & INDUSTRIAL SA | 2018-12-26 |
| 2018-11-21 | ||
| 2018-11-15 | ||
| COMPACT 300 | GE MEDICAL SYSTEMS, LLC | 2018-06-22 |
| COMPACT 300 | GE MEDICAL SYSTEMS, LLC | 2017-08-04 |
| PHILIPS MEDIO 65 CP | PHILIPS MEDICAL SYSTEMS | 2017-01-09 |
| ADVANTX | GE MEDICAL SYSTEMS SCS | 2014-03-26 |
| PHILIPS X-RAY | 2013-05-21 | |
| ADVANTX LC+ | GE MEDICAL SYSTEMS SCS | 2013-03-21 |
| SIEMENS-MAGALIX CATH PLUS 121GW BI PLANE IMAGING SYSTEM | SIEMENS FLUKE-V-451P | 2013-03-14 |
| ADVANTX LC+ | GE MEDICAL SYSTEMS SCS | 2013-02-12 |
| ADVANTX-E LC+ | GE MEDICAL SYSTEMS SCS | 2013-02-06 |
| ADVANTX LC+ | GE MEDICAL SYSTEMS SCS | 2012-12-13 |
| POLYDOROS | SIEMANS MEDICAL | 2012-10-25 |
| SETROX S 45 | BIOTRONIK SE & CO. KG | 2012-09-12 |
| DEXTRUS 4135 | BIOTRONIK SE & CO. KG | 2012-09-12 |
| PHILOS DR | BIOTRONIK SE & CO. KG | 2012-07-02 |
| DEXTRUS 4136 | BIOTRONIK SE & CO. KG | 2012-03-05 |
| ADVANTX LC+ | GE MEDICAL SYSTEMS | 2012-01-06 |
| ADVANTA LCA | GE MEDICAL SYSTEMS | 2011-12-28 |
| ADVANTX LCA | GE MEDICAL SYSTEMS | 2011-12-28 |
| ADVANTX LC | GE MEDICAL SYSTEMS | 2011-12-13 |
| ADVANTA LC+ | GE MEDICAL SYSTEMS | 2011-11-29 |
| INFO REQUESTED FROM HOSP | UNK | 2011-11-15 |
| TOSHIBA | TOSHIBA MEDICAL SYSTEMS CORPORATION | 2011-09-02 |
| INNOVA 2000 | GE MEDICAL SYSTEMS, LLC | 2011-08-23 |
| OPTITOP | SIEMENS MEDICAL SOLUTIONS USA, INC. | 2011-08-17 |
| ADVANTX LC+ | GE MEDICAL SYSTEMS | 2011-03-25 |
| ADVANTX LC+ | GE MEDICAL SYSTEMS SCS | 2011-03-14 |
| LC VASCULAR + | GE MEDICAL SYSTEMS | 2011-03-14 |
| LC VASCULAR + | GE MEDICAL SYSTEMS | 2011-03-03 |
| ADVANTX LC+ | GE MEDICAL SYSTEMS SCS | 2011-03-03 |
| ADVANTX LC+ | GE MEDICAL SYSTEMS SCS | 2011-03-03 |
| APX 525 X-RAY GENERATOR | DEL MEDICAL INC. | 2011-01-14 |
| XRAY | 2010-08-04 | |
| X-RAY MACHINE | 2009-09-03 | |
| SUINSA | SUINSA | 2009-05-07 |
| AXIOM ARISTOS FX | SIEMENS AG | 2008-10-31 |
| SIREMOBIL COMPACT | SIEMENS MEDICAL SOLUTIONS USA, INC. | 2008-09-15 |
| SILHOUETTE 20 HF | GE MEDICAL SYSTEMS, LLC | 2008-07-25 |
| SEDECAL | SEDECAL S.A. | 2008-07-10 |
| ADVANTX LC | GE MEDICAL SYSTEMS SCS | 2008-05-22 |
| SEDECAL | SEDECAL S.A. | 2007-10-22 |
| OPTIVANTAGE DH | LIEBEL-FLARSHEIM CO. | 2007-03-01 |
| *X-RAY SYSTEM, RADIOGRAPHIC | GE MEDICAL SYSTEMS, LLC | 2007-01-18 |