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 |
|---|---|---|---|
| Feb 22, 1988 | K875106 | PB-A LEAD-ACID BATTERY CONVERSION KIT Diagnostic Imaging Specialists Corp., CA | IZL |
| Jan 11, 1988 | K874840 | BENNETT PORTABLE RADIOGRAPHIC SYSTEM NO. SPR-100A Bennett X-Ray Corp. | IZL |
| Oct 30, 1987 | K873982 | GX-MOBILE X-RAY UNIT Gendex Corp. | IZL |
| Jul 22, 1986 | K862452 | MX MOBILE X-RAY SYSTEM Philips Medical Systems (Cleveland), Inc. | IZL |
| Jun 16, 1986 | K862118 | MODEL MBA-130 MOBILE X-RAY SYSTEM Elscint, Inc. | IZL |
| Apr 18, 1985 | K850678 | AIM N' SHOOT - AUTOMATIC EXPOSURE CONTROL Fairchild Medical Systems, Inc. | IZL |
| Sep 5, 1984 | K843192 | APR MOBILE Philips Medical Systems (Cleveland), Inc. | IZL |
| Nov 21, 1983 | K833239 | PORTA. X-RAY UNIT FP220 SCM-1-ETC, Showa X-Ray Co., Ltd. | IZL |
| Oct 28, 1983 | K833226 | PMX MOBILE X-RAY SYSTEM Philips Medical Systems, Inc. | IZL |
| Dec 3, 1981 | K813128 | MOBIL-AID AUTOMATIC EXPOSURE CONTROL Advanced Instrument Development, Inc. | IZL |
| May 21, 1981 | K811082 | BETA I & BETA II Porta Ray, Inc. | IZL |
| Mar 11, 1981 | K810276 | ALPHA I AND ALPHA II Porta Ray, Inc. | IZL |
| Jan 22, 1981 | K803103 | TECHNY REX 3000 MOBILE X-RAY UNIT Tecnomed, Inc. | IZL |
| Oct 23, 1980 | K802047 | AMX-III General Electric Co. | IZL |
| Jan 29, 1980 | K792665 | PIXIE Porta Ray, Inc. | IZL |
| May 4, 1979 | K790673 | OMNIMEDICAL AUTOMATIC 1001 Omnimedical | IZL |
| Mar 28, 1979 | K790451 | X-RAY UNITS, GX-101, UCIS-510 AND GX-111 General X-Ray, Inc. | IZL |
| Mar 26, 1979 | K790512 | PORTABLE X-RAY UNIT General X-Ray, Inc. | IZL |
| Mar 26, 1979 | K790511 | MOBILE X-RAY UNIT General X-Ray, Inc. | IZL |
| Mar 26, 1979 | K790443 | PORTABLE X-RAY UNIT General X-Ray, Inc. | IZL |
| Mar 26, 1979 | K790393 | PORTABLE X-RAY UNIT, MATRIX S GX-101 General X-Ray, Inc. | IZL |
| Mar 26, 1979 | K790392 | 510 CARBINETTE X-RAY UNIT General X-Ray, Inc. | IZL |
| Jan 17, 1979 | K782155 | GENERAL EQUIPMENT COVER Contour Fabricators, Inc. | IZL |
| Dec 4, 1978 | K781982 | INCLINOMETER, VERMONT Associates IN Radiology, Inc. | IZL |
| Dec 4, 1978 | K781976 | MOBILE X-RAY UNIT General X-Ray, Inc. | IZL |
| Dec 4, 1978 | K781975 | MOBILE CARRIER General X-Ray, Inc. | IZL |
| Oct 24, 1978 | K781705 | MOBIL XR Siemens Corp. | IZL |
| Oct 17, 1978 | K781676 | X-RAY STAND, PORTABLE General X-Ray, Inc. | IZL |
| Oct 3, 1978 | K781590 | PORTABLE X-RAY UNIT General X-Ray, Inc. | IZL |
| Sep 11, 1978 | K781425 | CAP-MOBILE Philips Medical Systems (Cleveland), Inc. | IZL |
| Aug 10, 1978 | K781276 | X-RAY, PORTABLE Air-Shields, Inc. | IZL |
| Jul 17, 1978 | K781030 | X-RAY UNIT, PORTABLE GX-101 AEC General X-Ray, Inc. | IZL |
| Jun 27, 1978 | K780999 | X-RAY FRAME HOLDER Great Eastern Lumber Co., Inc. | IZL |
| Jun 22, 1978 | K780947 | 510 BEDSIDE X-RAY SYSTEM Union Carbide Corp. | IZL |
| Mar 14, 1978 | K780313 | HITACHI TECH-MOBLE DHC-121 Philips Medical Systems (Cleveland), Inc. | IZL |
| Aug 25, 1977 | K771571 | MOBILE X-RAY SYS. MODEL 43820A Hewlett-Packard Co. | IZL |
| Jun 29, 1977 | K770903 | STERILE CONTINER, X-RAY CASSETTE HOLDER North Shore Orthopaedic Group, S.C. | IZL |
| Oct 5, 1976 | K760741 | PORTABLE X-RAY Minxray, Inc. | IZL |
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