System, X-Ray, Mobile
Regulation 892.1720
7510(k)s in 12 months (238 all time)
5recalls in 12 months (173 all time)
161recalls that name a 510(k)
Top companies in IZL
| Company | 510(k)s | Recalls |
|---|---|---|
| Sedecal USA, Inc. | 19 | 58 |
| Siemens Medical Solutions | 6 | 18 |
| Carestream Health | 7 | 13 |
| GE Medical Systems | 8 | 10 |
| Minxray, Inc. | 15 | 0 |
| GE Healthcare | 0 | 14 |
| Micro-X , Ltd. | 2 | 10 |
| General X-Ray, Inc. | 11 | 0 |
| Shimadzu Medical Systems | 1 | 8 |
| Samsung Electronics Co., Ltd. | 8 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2002 | K022337 | 3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D Siemens Medical Solutions USA, Inc. | IZL |
| Jun 17, 2002 | K021016 | AMX-4 PLUS MOBILE X-RAY SYSTEM GE Medical Systems | IZL |
| Feb 22, 2002 | K020436 | PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 Sedecal., Sa. | IZL |
| Aug 31, 2001 | K012663 | EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) Sedecal USA, Inc. | IZL |
| Aug 16, 2001 | K012379 | PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM Trex Enterprises Corp. | IZL |
| Feb 12, 2001 | K010304 | MXR-2000 MOBILE X-RAY UNIT Irom Imaging, Inc. | IZL |
| Sep 15, 2000 | K002685 | CORDLESS COMPACT MOBILE X-RAY SYSTEM Medison Radiology Systems, Inc. | IZL |
| Jun 27, 2000 | K001517 | SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES Shimadzu Corp. | IZL |
| Aug 6, 1999 | K992229 | MXU-125 OR TMX-125 Trex Medical Corp. | IZL |
| Jul 14, 1998 | K981466 | XR-910 Imaging Sciences Intl., Inc. | IZL |
| Dec 30, 1997 | K973833 | CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL Dynarad Corp. | IZL |
| Dec 12, 1997 | K973712 | MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT Minxray, Inc. | IZL |
| Dec 12, 1997 | K972365 | COMPACT OR COMP-X Eurotec, S.R.L., IT | IZL |
| Oct 8, 1997 | K972204 | ACU-RAY HF SERIES PORTABLE X-RAY UNIT Sterne Equipment Co., Ltd., CA | IZL |
| May 2, 1997 | K970234 | SEALED LEAD ACID BATTERY PACK Portable Power Systems, Inc. | IZL |
| Dec 22, 1995 | K955036 | MOBILE X-RAY SYSTEM Shimadzu Corp., JP | IZL |
| Dec 21, 1995 | K955095 | SIERRA BATTERY SEALED LEAD ACID BATTERY SYSTEM Sierra Battery, Inc. | IZL |
| Nov 30, 1995 | K953404 | OSTEO-RAY 100 Micro Focus Imaging, Inc. | IZL |
| Nov 22, 1995 | K953292 | CP 100/30 Micro-Focus Imaging., Inc. | IZL |
| Mar 14, 1995 | K944442 | GENERAL ELECTRIC AMX 110, AMX II AND AMX 3 Pro-Tronics, Inc. | IZL |
| Jan 20, 1995 | K945043 | BATTERY PACK #PMX120-18A Portable Power Systems, Inc. | IZL |
| Jan 19, 1995 | K945707 | MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT Minxray, Inc. | IZL |
| Sep 14, 1994 | K932106 | MOBILETT PLUS MOBILE X-RAY SYSTEM Siemens Medical Solutions USA, Inc. | IZL |
| Jul 20, 1994 | K941363 | PHANTOM Dynarad Corp. | IZL |
| Feb 17, 1994 | K931483 | REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH. Portable Power Systems, Inc. | IZL |
| Jan 31, 1994 | K932353 | HF-110A Dynarad Corp. | IZL |
| Jan 24, 1994 | K934818 | HAND HELD DENTAL X-RAY DEVICE Dept. of the Army | IZL |
| Nov 3, 1993 | K931279 | ACU-RAY Sterne Equipment Co., Ltd., CA | IZL |
| Aug 9, 1993 | K930699 | M6-M X-Cel X-Ray Corp. | IZL |
| Aug 3, 1993 | K932355 | 9150A, 1100F Dynarad Corp. | IZL |
| Jul 23, 1993 | K932354 | 9170, 1170 Dynarad Corp. | IZL |
| Jul 13, 1993 | K931200 | BATTERY PACKS (VARIOUS MODELS) Access / God Loves You | IZL |
| Jun 22, 1993 | K930049 | INFRARED EXPOSURE HAND SWITCH Mid X-Ray, Inc. | IZL |
| Apr 7, 1993 | K923359 | PORT-XP Mobile Dental Equipment Corp. | IZL |
| Oct 16, 1992 | K924798 | BATTERY PACK Portable Power Systems, Inc. | IZL |
| Oct 5, 1992 | K921116 | PX-100 PORTABLE X-RAY GENERATOR Acoma Medical Imaging, Inc. | IZL |
| Aug 27, 1992 | K921425 | SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R Acoma Medical Imaging, Inc. | IZL |
| Sep 9, 1991 | K910902 | VMX MOBILE X-RAY SYSTEM GE Medical Systems | IZL |
| Sep 6, 1991 | K912323 | THE REMOTE Remote Technologies, Inc. | IZL |
| Aug 26, 1991 | K911841 | MINXRAY P300 X-RAY SYSTEM Minxray, Inc. | IZL |
| Aug 9, 1991 | K912400 | MOBILE X-RAY FLOOR STAND Dntl Corp. | IZL |
| Oct 26, 1990 | K902984 | G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS Electromek Diagnostic Systems, Inc. | IZL |
| Jul 2, 1990 | K902610 | GENERAL ELECTRIC AMX 3 Pro-Tronics, Inc. | IZL |
| Dec 14, 1989 | K894643 | RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT Lorad Medical Systems, Inc. | IZL |
| Sep 1, 1989 | K894021 | MOBILE X-RAY UNIT Ziehm International, Inc. | IZL |
| Jul 20, 1989 | K893637 | MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM Shimadzu Medical Systems | IZL |
| May 3, 1989 | K891143 | GENERAL ELECTRIC AMX 110 Pro-Tronics, Inc. | IZL |
| May 1, 1989 | K891142 | GENERAL ELECTRIC AMX II Pro-Tronics, Inc. | IZL |
| Apr 17, 1989 | K890306 | BCM-ARC 105 X-RAY MOBILE UNIT B C Medical , Ltd., CA | IZL |
| Oct 13, 1988 | K883092 | BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR Bennett X-Ray Corp. | IZL |
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