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 |
| 5277 | Assembly, Tube Housing, X-ray, Diagnostic | Diagnostic X-ray Tube Housing Assembly. |
| 5277 | Assembly, Tube Housing, X-ray, Diagnostic | Diagnostic X-ray Tube Housing Assembly. |
| Assembly, Tube Housing, X-Ray, Diagnostic [37593] | 21 CFR §892.1760 🔎 |
| Assembly, Tube Housing, X-Ray, Diagnostic [37630] | 21 CFR §892.1760 🔎 |
| Assembly, Tube Housing, X-Ray, Diagnostic [37992] | 21 CFR §892.1760 🔎 |
| Assembly, Tube Housing, X-Ray, Diagnostic [15092] | 21 CFR §892.1760 🔎 |
| K000052 | X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 | DYNARAD CORP. |
| K933162 | MRX-750 | MRX CORP. |
| K923094 | MOLYBDENUM | SOUTHEASTERN MEDICAL DIAGNOSTICS, INC. |
| K921316 | MG-1001 TUBE HOUSING ASSEMBLY | MAGMA CORP. |
| K921129 | MRX-700 | MRX-RAY TUBE CORP. |
| K921130 | MRX-865 | MRX-RAY TUBE CORP. |
| K920731 | X-RAY TUBE ASSEMBLY CIRCLEX1.2UG | SHIMADZU MEDICAL SYSTEMS |
| K920723 | HIGH SPEED ROTATION STARTER SA-40 | SHIMADZU MEDICAL SYSTEMS |
| K920724 | HIGH SPEED ROTATION STARTER SA-50 | SHIMADZU MEDICAL SYSTEMS |
| K920387 | CIRCLEXO.3T X-RAY TUBE ASSEMBLY | SHIMADZU MEDICAL SYSTEMS |
| K913987 | OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID | Codman & Shurtleff, Inc. |
| K913301 | MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM | COMET NORTH AMERICA, INC. |
| K912338 | TUBE HOUSING ASSEMBLIES | COMET LTD. C/O RADIOLOGY RESOURCES, INC. |
| K911695 | VARIOUS X-RAY TUBES | COMET LTD. C/O RADIOLOGY RESOURCES, INC. |
| K910842 | DI2000/HS-45-150 X-RAY TUBE INSERT | COMET LTD. C/O RADIOLOGY RESOURCES, INC. |
| 00884838093034 | Assembly, tube housing, x-ray, diagnostic |
| 00884838093010 | Assembly, tube housing, x-ray, diagnostic |
| 00884838093003 | Assembly, tube housing, x-ray, diagnostic |
| 00884838092990 | Assembly, tube housing, x-ray, diagnostic |
| 00884838092983 | Assembly, tube housing, x-ray, diagnostic |
| 00884838092976 | Assembly, tube housing, x-ray, diagnostic |
| 00884838092969 | Assembly, tube housing, x-ray, diagnostic |
| 00884838092952 | Assembly, tube housing, x-ray, diagnostic |
| 00884838092945 | Assembly, tube housing, x-ray, diagnostic |
| 00884838092921 | Assembly, tube housing, x-ray, diagnostic |
| 00884838092914 | Assembly, tube housing, x-ray, diagnostic |
| 00884838092907 | Assembly, tube housing, x-ray, diagnostic |
| 00884838092891 | Assembly, tube housing, x-ray, diagnostic |
| 00884838092884 | Assembly, tube housing, x-ray, diagnostic |
| 00884838092877 | Assembly, tube housing, x-ray, diagnostic |
| VARIAN | VARIAN MEDICAL SYSTEMS | 2012-04-27 |
| ASSEMBLY, 9300XSP L/S W/APSW T | INTEGRA, BURLINGTON | 2011-09-30 |
| VARIAN | VARIAN MEDICAL SYSTEMS | 2011-02-11 |
| 104181 EASYDIAGNOST 9" II DSI-U | PHILIPS MEDICAL SYSTEMS NORTH AMERICA | 2009-01-29 |
| FINAL ASSY, DR1000 | LIEBEL - FLARSHEIM CO. | 2009-01-07 |
| SUPPORT ARM | MAQUET CRITICAL CARE AB | 2006-07-14 |
| D3112T TUBE | GE MEDICAL SYSTEMS SCS | 2005-11-22 |
| ADNEXA | ADNEXA CORP | 2005-10-20 |
| B & K ULTRASOUND MACHINE | B-K MEDICAL | 2004-07-14 |
| TRAUMEX | FISCHER IMAGING CORP. | 2004-05-05 |
| HTG CASING | G.E. MEDICAL SYSTEMS | 2004-03-25 |
| UROPRO UROLOGY IMAGING SYSTEM | ARCOMA AB | 2003-07-31 |
| *LEAD FILTER | * | 2003-07-28 |
| SIEMENS | SIEMENS | 2003-01-21 |
| SAPPHIRE 150TH / RAD 21 | VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS | 2001-12-05 |
| ATLANTIS SR (IVWS) | BOSTON SCIENTIFIC SCIMED | 2001-10-02 |
| SRO 33/100 X-RAY TUBE ASSEMBLY | PHILIPS MEDEZIN SYSTEME | 2001-06-29 |
| 2001-06-29 | ||
| GENERAL ELECTRIC | GENERAL ELECTRIC | 2001-06-15 |
| TRAUMEX | FISCHER IMAGING CORP. | 2001-06-07 |
| *X-RAY TUBE | GE MEDICAL SYSTEMS | 2001-04-19 |
| NIX-RAY TUBE | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. | 2000-04-07 |
| ELITE 1500E | FISCHER IMAGING CORP. | 2000-02-16 |
| ** | FISCHER IMAGING CORP. | 1999-12-22 |
| VARIAN A292/B150 | VARIAN INTERAY | 1998-10-15 |
| MACHLETT-DYNAMAX 50 | VARIAN X-RAY TUBE PRODUCTS | 1998-09-29 |
| LIEBEL FLARSHEIM | EUREKA X-RAY TUBE CO. | 1998-08-07 |
| APOLLO X-RAY TUBE CEILING | PICKER INT'L., INC. | 1998-02-17 |
| FISCHER IMAGING CORP | FISCHER IMAGING CORP | 1997-12-31 |
| SAPPHIRE / RAD-60 S/N AT47337 | VARIAN X-RAY TUBE PRODUCTS | 1997-12-19 |
| RAD 60 X-RAY TUBE | VARIAN ASSOCIATES INC. | 1997-12-15 |
| GENERAL ELECTRIC | GENERAL ELECTRIC MEDICAL SYSTEMS | 1997-10-28 |
| BUCKY DIAGNOST CS 2 | PHILIPS SYSTEME MEDEZIN | 1997-07-25 |
| TOSHIBA | TOSHIBA CORPORATION | 1997-06-13 |
| TRAUMEX | FISCHER IMAGING CORP. | 1997-06-09 |
| CARDIAC CX | FISCHER IMAGING CORP. | 1997-05-12 |
| ** | * | 1997-05-12 |
| SUSPENSION TYPE 6 | GENERAL ELECTRIC CO. | 1997-05-01 |
| SRO 33/100 X-RAY TUBE ASSEMBLY | PHILIPS SYSTEME MEDEZIN | 1997-03-26 |
| DOUBLE MONITOR SUSPENSION | GE MEDICAL SYS | 1997-03-04 |
| STORZ IMAGING SYSTEM C-ARM | FISHER IMAGING CORP. | 1997-02-26 |
| SOLARIX TUBE/BUCKY STAND | GE MEDICAL SYSTEMS EUROPE | 1997-01-30 |
| BENNETT S82RM6 | BENNETT, SUBSIDIARY OF TREX MED. | 1997-01-24 |
| SAPPHIRE 150TH | VARIAN X-RAY TUBE PRODUCTS | 1997-01-09 |
| FOUR MONITOR SUSPENSION | PHILIPS MEDICAL SYSTEMS NORTH AMERICA | 1996-11-19 |
| EDEC 80 X-RAY MACHINE AND CGR | UNK | 1996-07-13 |
| EDEC 80 X-RAY MACHINE | UNK | 1996-07-13 |
| G.E. PRESTILIX 1600S | G.E. MEDICAL SYSTEMS | 1995-07-06 |
| TUBE HOUSING ASSEMBLY | PICKER INTL. | 1995-05-23 |
| *HIGH PRESSURE TUBING | MERIT MEDICAL SYSTEMS, INC. | 1995-02-15 |