FDA Product Code
FDA Product Code IZL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1720
510(k) Clearances — 238 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K150097 | GM60A-32S & GM60A-40S | Samsung Electronics Co., Ltd. | 2015-02-19 | Traditional | PDF ↗ |
| K142492 | GM60A-32S, GM60A-40S | Samsung Electronics Co., Ltd. | 2014-12-17 | Traditional | PDF ↗ |
| K141539 | KUBTEC X250 | Kub Technologies, Inc. | 2014-10-29 | Traditional | PDF ↗ |
| K142383 | Optima XR200amx, Optima XR220amx | Ge Medical Systems, LLC | 2014-09-25 | Special | PDF ↗ |
| K141895 | MOBILEDIAGNOST WDR | Sedecal., Sa. | 2014-09-18 | Special | PDF ↗ |
| K141885 | CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY | Minxray, Inc. | 2014-09-18 | Special | PDF ↗ |
| K140723 | NOMAD MD 75K V HANDHELD X-RAY SYSTEM | Aribex, Inc. | 2014-08-19 | Traditional | PDF ↗ |
| K122298 | AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR | Ajex Meditech., Ltd. | 2014-03-28 | Traditional | PDF ↗ |
| K122697 | PORTA 100HF | Job Corporation | 2012-10-05 | Traditional | PDF ↗ |
| K121410 | DRAGON LW | Sedecal., Sa. | 2012-08-02 | Special | PDF ↗ |
| K120062 | DRX-REVOLUTION MOBILE X-RAY SYSTEM | Carestream Health, Inc. | 2012-04-13 | Traditional | PDF ↗ |
| K111912 | MOBILETT MIRA | Siemens Medical Solutions USA, Inc. | 2011-09-19 | Special | PDF ↗ |
| K101517 | SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY | Sedecal., Sa. | 2011-08-05 | Special | PDF ↗ |
| K111725 | MOBILEDIAGNOST WDR | Sedecal., Sa. | 2011-07-19 | Special | PDF ↗ |
| K103476 | BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX | Ge Medical Systems, LLC | 2011-06-16 | Traditional | PDF ↗ |
| K103522 | SEDECAL | Sedecal., Sa. | 2011-01-26 | Special | PDF ↗ |
| K103597 | DX-D 100 | Agfa Healthcare N.V. | 2011-01-03 | Traditional | PDF ↗ |
| K092713 | SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM | Transamerican Medical Imaging | 2010-07-16 | Traditional | PDF ↗ |
| K100449 | MINXRAY MODEL CMDR-2S | Minxray, Inc. | 2010-04-23 | Traditional | PDF ↗ |
| K100400 | PRESTODR PORTABLE | Cmt Medical Technologies, Ltd. | 2010-04-22 | Special | PDF ↗ |
| K090655 | PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260 | Source-Ray, Inc. | 2009-07-14 | Traditional | PDF ↗ |
| K090268 | SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION | Shimadzu Corp. | 2009-06-30 | Abbreviated | PDF ↗ |
| K090322 | EASY MOVING PLUS, SM-XXHF-YY | Sedecal., Sa. | 2009-03-17 | Special | PDF ↗ |
| K083048 | NEORAY DR 2520 DIGITAL IMAGING SYSTEM | Portavision Medical, LLC | 2008-11-21 | Traditional | PDF ↗ |
| K082627 | MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL | Minxray, Inc. | 2008-11-07 | Traditional | PDF ↗ |
| K080701 | SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION | Shimadzu Corp. | 2008-05-14 | Abbreviated | PDF ↗ |
| K080945 | FCR GO PORTABLE DIGITAL X-RAY SYSTEM | Fujifilm Medical Systems U.S.A, Inc. | 2008-04-18 | Traditional | PDF ↗ |
| K072392 | OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM | Siemens Medical Solutions USA, Inc. | 2007-09-25 | Special | PDF ↗ |
| K070634 | SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110 | Soyee Product, Inc. | 2007-07-11 | Traditional | PDF ↗ |
| K071015 | OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM | Siemens Medical Solutions USA, Inc. | 2007-05-10 | Special | PDF ↗ |
| K063262 | AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS | Virtual Imaging | 2006-12-26 | Traditional | PDF ↗ |
| K062472 | OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115 | Source-Ray, Inc. | 2006-10-31 | Traditional | PDF ↗ |
| K061685 | PULSERA | Philips Medical Systems North America Co. | 2006-09-15 | Traditional | PDF ↗ |
| K060566 | MINXRAY, MODELS HFP24 AND HFP40 | Mikasa X-Ray Co., Ltd. | 2006-04-05 | Special | PDF ↗ |
| K052897 | GE DEFINIUM AMX 700, MODEL AMX 700 | General Electric Medical Systems | 2005-11-08 | Special | PDF ↗ |
| K052721 | MINXRAY, MODEL HF100H+ | Minxray, Inc. | 2005-10-27 | Special | PDF ↗ |
| K052341 | AJEX 9015/135H PORTABLE X-RAY | Jpi America, Inc. | 2005-10-07 | Traditional | PDF ↗ |
| K052001 | MODEL SR-115 PORTABLE X-RAY SYSTEM | Source-Ray, Inc. | 2005-08-11 | Traditional | PDF ↗ |
| K043062 | MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM | Source-Ray, Inc. | 2004-12-13 | Traditional | PDF ↗ |
| K043002 | SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR | Sedecal., Sa. | 2004-11-18 | Special | PDF ↗ |
| K042866 | AMX5 AND AMX5D MOBILE X-RAY SYSTEMS | Ge Healthcare Technologies | 2004-11-02 | Traditional | PDF ↗ |
| K042368 | PRACTIX CONVENIO | Philips Medical Systems North America Co. | 2004-10-04 | Abbreviated | PDF ↗ |
| K042361 | DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D | Sedecal USA, Inc. | 2004-09-29 | Special | PDF ↗ |
| K041922 | GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR | General Electric Co. | 2004-07-28 | Special | PDF ↗ |
| K041763 | SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES | Shimadzu Corp. | 2004-07-13 | Traditional | PDF ↗ |
| K032628 | PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF | United Radiology Systems, Inc. | 2004-02-02 | Traditional | PDF ↗ |
| K040046 | MINXRAY, MODEL HF120/60H POWERPLUS | Minxray, Inc. | 2004-02-02 | Special | PDF ↗ |
| K033238 | MOBILETTE XP AND MOBILETT XPHYBRID | Siemens Medical Systems, Inc. | 2003-11-14 | Special | PDF ↗ |
| K032280 | SIREMOBIL ISO-C 3D | Siemens AG | 2003-09-10 | Abbreviated | PDF ↗ |
| K030494 | SR-130 | Source-Ray, Inc. | 2003-05-20 | Traditional | PDF ↗ |
| K022337 | 3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D | Siemens Medical Solutions USA, Inc. | 2002-08-13 | Special | PDF ↗ |
| K021016 | AMX-4 PLUS MOBILE X-RAY SYSTEM | GE Medical Systems | 2002-06-17 | Traditional | PDF ↗ |
| K020436 | PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 | Sedecal., Sa. | 2002-02-22 | Abbreviated | PDF ↗ |
| K012663 | EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) | Sedecal USA, Inc. | 2001-08-31 | Traditional | PDF ↗ |
| K012379 | PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM | Trex Enterprises Corp. | 2001-08-16 | Traditional | PDF ↗ |
| K010304 | MXR-2000 MOBILE X-RAY UNIT | Irom Imaging, Inc. | 2001-02-12 | Traditional | PDF ↗ |
| K002685 | CORDLESS COMPACT MOBILE X-RAY SYSTEM | Medison Radiology Systems, Inc. | 2000-09-15 | Abbreviated | PDF ↗ |
| K001517 | SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES | Shimadzu Corp. | 2000-06-27 | Abbreviated | PDF ↗ |
| K992229 | MXU-125 OR TMX-125 | Trex Medical Corp. | 1999-08-06 | Traditional | PDF ↗ |
| K981466 | XR-910 | Imaging Sciences Intl., Inc. | 1998-07-14 | Traditional | PDF ↗ |
| K973833 | CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL | Dynarad Corp. | 1997-12-30 | Traditional | PDF ↗ |
| K973712 | MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT | Minxray, Inc. | 1997-12-12 | Traditional | PDF ↗ |
| K972365 | COMPACT OR COMP-X | Eurotec, S.R.L. | 1997-12-12 | Traditional | PDF ↗ |
| K972204 | ACU-RAY HF SERIES PORTABLE X-RAY UNIT | Sterne Equipment Co., Ltd. | 1997-10-08 | Traditional | PDF ↗ |
| K970234 | SEALED LEAD ACID BATTERY PACK | Portable Power Systems, Inc. | 1997-05-02 | Traditional | PDF ↗ |
| K955036 | MOBILE X-RAY SYSTEM | Shimadzu Corp. | 1995-12-22 | Traditional | PDF ↗ |
| K955095 | SIERRA BATTERY SEALED LEAD ACID BATTERY SYSTEM | Sierra Battery, Inc. | 1995-12-21 | Traditional | PDF ↗ |
| K953404 | OSTEO-RAY 100 | Micro Focus Imaging, Inc. | 1995-11-30 | Traditional | PDF ↗ |
| K953292 | CP 100/30 | Micro-Focus Imaging., Inc. | 1995-11-22 | Traditional | PDF ↗ |
| K944442 | GENERAL ELECTRIC AMX 110, AMX II AND AMX 3 | Pro-Tronics, Inc. | 1995-03-14 | Traditional | PDF ↗ |
| K945043 | BATTERY PACK #PMX120-18A | Portable Power Systems, Inc. | 1995-01-20 | Traditional | PDF ↗ |
| K945707 | MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT | Minxray, Inc. | 1995-01-19 | Traditional | PDF ↗ |
| K932106 | MOBILETT PLUS MOBILE X-RAY SYSTEM | Siemens Medical Solutions USA, Inc. | 1994-09-14 | Traditional | PDF ↗ |
| K941363 | PHANTOM | Dynarad Corp. | 1994-07-20 | Traditional | PDF ↗ |
| K931483 | REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH. | Portable Power Systems, Inc. | 1994-02-17 | Traditional | PDF ↗ |
| K932353 | HF-110A | Dynarad Corp. | 1994-01-31 | Traditional | PDF ↗ |
| K934818 | HAND HELD DENTAL X-RAY DEVICE | Dept. of the Army | 1994-01-24 | Traditional | PDF ↗ |
| K931279 | ACU-RAY | Sterne Equipment Co., Ltd. | 1993-11-03 | Traditional | PDF ↗ |
| K930699 | M6-M | X-Cel X-Ray Corp. | 1993-08-09 | Traditional | PDF ↗ |
| K932355 | 9150A, 1100F | Dynarad Corp. | 1993-08-03 | Traditional | PDF ↗ |
| K932354 | 9170, 1170 | Dynarad Corp. | 1993-07-23 | Traditional | PDF ↗ |
| K931200 | BATTERY PACKS (VARIOUS MODELS) | Access / God Loves You | 1993-07-13 | Traditional | PDF ↗ |
| K930049 | INFRARED EXPOSURE HAND SWITCH | Mid X-Ray, Inc. | 1993-06-22 | Traditional | PDF ↗ |
| K923359 | PORT-XP | Mobile Dental Equipment Corp. | 1993-04-07 | Traditional | PDF ↗ |
| K924798 | BATTERY PACK | Portable Power Systems, Inc. | 1992-10-16 | Traditional | PDF ↗ |
| K921116 | PX-100 PORTABLE X-RAY GENERATOR | Acoma Medical Imaging, Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K921425 | SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R | Acoma Medical Imaging, Inc. | 1992-08-27 | Traditional | PDF ↗ |
| K910902 | VMX MOBILE X-RAY SYSTEM | GE Medical Systems | 1991-09-09 | Traditional | PDF ↗ |
| K912323 | THE REMOTE | Remote Technologies, Inc. | 1991-09-06 | Traditional | PDF ↗ |
| K911841 | MINXRAY P300 X-RAY SYSTEM | Minxray, Inc. | 1991-08-26 | Traditional | PDF ↗ |
| K912400 | MOBILE X-RAY FLOOR STAND | Dntl Corp. | 1991-08-09 | Traditional | PDF ↗ |
| K902984 | G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS | Electromek Diagnostic Systems, Inc. | 1990-10-26 | Traditional | PDF ↗ |
| K902610 | GENERAL ELECTRIC AMX 3 | Pro-Tronics, Inc. | 1990-07-02 | Traditional | PDF ↗ |
| K894643 | RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT | Lorad Medical Systems, Inc. | 1989-12-14 | Traditional | PDF ↗ |
| K894021 | MOBILE X-RAY UNIT | Ziehm International, Inc. | 1989-09-01 | Traditional | PDF ↗ |
| K893637 | MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM | Shimadzu Medical Systems | 1989-07-20 | Traditional | PDF ↗ |
| K891143 | GENERAL ELECTRIC AMX 110 | Pro-Tronics, Inc. | 1989-05-03 | Traditional | PDF ↗ |
| K891142 | GENERAL ELECTRIC AMX II | Pro-Tronics, Inc. | 1989-05-01 | Traditional | PDF ↗ |
| K890306 | BCM-ARC 105 X-RAY MOBILE UNIT | B C Medical , Ltd. | 1989-04-17 | Traditional | PDF ↗ |
| K883092 | BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR | Bennett X-Ray Corp. | 1988-10-13 | Traditional | PDF ↗ |
Product code IZL · Class II · Radiology. Data: openFDA.