Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 29
- Latest Decision
- 2009-02-02
Clearances · page 69 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K083667 | NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 | B-K Medical Aps | ITX | Class II | 2009-02-02 |
| K081556 | CADSTREAM, VERSION 5.0 | Confirma, Inc. | LLZ | Class II | 2009-02-02 |
| K083882 | MYLABFIVE | Esaote Europe B.V. | IYN | Class II | 2009-01-30 |
| K090009 | THD SLIDE ONE | Thd Spa | JAF | Class II | 2009-01-28 |
| K083618 | PACS SCAN | Pacsgear, Inc. | LLZ | Class II | 2009-01-28 |
| K090045 | COLOR LCD MONITOR, RADIFORCE RX320 | Eizo Nanao Corporation | LLZ | Class II | 2009-01-28 |
| K090044 | PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C | Oncolog Medical QA AB | IYE | Class II | 2009-01-22 |
| K083264 | RAYAUTOPLAN 1.0 | Raysearch Laboratories AB | MUJ | Class II | 2009-01-22 |
| K081797 | IMAGE STORAGE SYSTEM, MODEL KSS-400 | Konan Medical, Inc. | NFJ | Class II | 2009-01-22 |
| K083725 | RADPRO ION | Virtual Imaging, Inc. | OWB | Class II | 2009-01-22 |
| K083578 | NORAS CPC MULTIFUNCTIONAL COIL | Noras Mri Products GmbH | MOS | Class II | 2009-01-16 |
| K083149 | ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2009-01-14 |
| K083916 | LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD | Nec Display Solutions , Ltd. | LLZ | Class II | 2009-01-14 |
| K083877 | FLYING DIAGNOSTIC ULTRASOUND SYSTEM | Neusoft Medical Systems Co., Ltd. | ITX | Class II | 2009-01-13 |
| K083907 | MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG | Nec Display Solutions , Ltd. | LLZ | Class II | 2009-01-13 |
| K083166 | SPECIALTY COILS FOR THE MAGNETOM ESSENZA | Siemens Medical Solutions USA, Inc. | MOS | Class II | 2009-01-13 |
| K082808 | IMAGESVR PACS | Jaguar Technology Limited | LLZ | Class II | 2009-01-09 |
| K083061 | ELLEX INNOVATIVE IMAGING EYE CUBED V4 | Ellex, Inc. | IYO | Class II | 2009-01-09 |
| K083522 | SONY UP-DF750 DIGITAL FILM IMAGER | Sony Electronics, Inc. | LMC | Class II | 2009-01-09 |
| K083358 | LUBRICANO-ULTRASOUND | Farco Pharma GmbH | MUI | Class II | 2009-01-09 |
| K083332 | MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK | Nec Display Solutions , Ltd. | LLZ | Class II | 2009-01-09 |
| K083510 | KUBTEC XPERT 20 | Kub Technologies, Inc. | KPR | Class II | 2009-01-08 |
| K083274 | WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER | Biocompatibles, Inc. | KXK | Class II | 2009-01-08 |
| K082526 | CARDIO VUE QUANTITATIVE ANALYSIS (CVQ) | Mri Cardiac Services, Incorporated | LLZ | Class II | 2009-01-05 |
| K083673 | CARESTREAM PACS, MODEL CARESTREAM PACS VII | Carestream Health, Inc. | LLZ | Class II | 2008-12-30 |
| K083591 | IKOENGELO, VERSION 2 | Ikoetech, LLC | KPQ | Class II | 2008-12-29 |
| K083348 | IMAGE-ARENA APPLICATIONS | Tomtec Imaging Systems GmbH | LLZ | Class II | 2008-12-23 |
| K082909 | RSVP HALF SPHERE PHANTOM, MODEL DDP010 | The Phantom Laboratory, Inc. | IYE | Class II | 2008-12-23 |
| K083434 | TT1 GENERAL PURPOSE COIL | Tursiop Technologies, LLC | MOS | Class II | 2008-12-23 |
| K081148 | SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER | Siemens Medical Solutions USA, Inc., Ultrasound DI | IYO | Class II | 2008-12-22 |
| K083254 | ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM | Aloka Co., Ltd. | IYN | Class II | 2008-12-19 |
| K083084 | CT BRAIN PERFUSION FOR ZIOSTATION | Ziosoft, Inc. | LLZ | Class II | 2008-12-19 |
| K082904 | STASYS MOTION CORRECTION SOFTWARE | Digirad Corp. | KPS | Class II | 2008-12-17 |
| K083498 | PHILIPS MODEL MX 16 SLICE CT SYSTEM | Philips Medical Systems (Cleveland), Inc. | JAK | Class II | 2008-12-17 |
| K083555 | PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION | Emsoma Co., Ltd. | LLZ | Class II | 2008-12-16 |
| K083137 | NEURO III-SV | Imris, Inc. | LNH | Class II | 2008-12-16 |
| K082224 | DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC | Shimadzu Medical Systems | ITX | Class II | 2008-12-15 |
| K083282 | MODEL TSX-301B AQUILION CT SYSTEM | Toshiba America Medical Systems, In.C | JAK | Class II | 2008-12-12 |
| K082269 | VISAGE PACS, VERSION 6.0/CS 3.1 | Visage Imaging, Inc. | LLZ | Class II | 2008-12-12 |
| K082416 | IBA PROTON THERAPY SYSTEM- PROTEUS 235 | Ion Beam Applications S.A. | LHN | Class II | 2008-12-12 |
| K083504 | GE DISCOVERY NM/CT 570C | Ge Medical Systems F.I. Haifa | KPS | Class II | 2008-12-12 |
| K083505 | DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2008-12-12 |
| K083293 | VIATRONIX V3D-CARDIAC, REVISION 1.0 | Viatronix, Inc. | JAK | Class II | 2008-12-05 |
| K083086 | ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) | Hitachi Medical Systems America, Inc. | MOS | Class II | 2008-12-05 |
| K083029 | MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR | Ralco S.R.L. | IZW | Class II | 2008-12-05 |
| K082607 | MRI-PLAQUE VIEW, VERSION 1.1.2003 | Vpdiagnostics, Inc. | LLZ | Class II | 2008-12-05 |
| K081073 | HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F | Pausch, LLC | OWB | Class II | 2008-12-05 |
| K082893 | PRAGER SHELL | Esi, Inc. | ITX | Class II | 2008-12-05 |
| K083109 | SUINSA DIAGNOSTIC X-RAY SYSTEM | Suinsa | KPR | Class II | 2008-12-04 |
| K082456 | VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 | Verathon Incorporated | IYO | Class II | 2008-12-01 |
| K083181 | QV-9000 UNIVERSAL SYSTEM | Quantum Medical Imaging, LLC | KPR | Class II | 2008-11-26 |
| K072664 | GE LUNAR FEMUR STRENGTH SOFTWARE | Ge Medical Systems Ultrasound and Primary Care Dia | KGI | Class II | 2008-11-21 |
| K082441 | NORDICICE SOFTWARE | Nordicimaginglab AS | LLZ | Class II | 2008-11-21 |
| K082432 | CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM | Bioptics, Inc. | MWP | Class II | 2008-11-21 |
| K083255 | 16CH AI BREAST COILS 1.5 T AND 3 T | Rapid Biomedical GmbH | MOS | Class II | 2008-11-21 |
| K082604 | VIZTEK DR, MODELS: DR1000, DR3000, DR4000 | Viztek, Inc. | KPR | Class II | 2008-11-21 |
| K083048 | NEORAY DR 2520 DIGITAL IMAGING SYSTEM | Portavision Medical, LLC | IZL | Class II | 2008-11-21 |
| K082506 | SYMBIA, VERSION 4.0 | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2008-11-21 |
| K082240 | SNTRYPACS | Qstar Technologies, Inc. | LLZ | Class II | 2008-11-20 |
| K082628 | CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 | Circle Cardiovascular Imaging, Inc. | LLZ | Class II | 2008-11-20 |
| K082990 | INFINITT XELIS | Infinitt Co., Ltd. | LLZ | Class II | 2008-11-20 |
| K082773 | STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 | Standard Imaging, Inc. | IYE | Class II | 2008-11-19 |
| K083227 | VIDA PULMONARY WORKSTATION 2 (PW2) | Vida Diagnostics, Inc. | JAK | Class II | 2008-11-18 |
| K082347 | DIGITAL RADIOGRAPHY, FLEXDR C30 | Konica Minolta Technoproduct Co., Ltd. | MQB | Class II | 2008-11-18 |
| K082907 | IC-PRO SYSTEM, VERSION 3.1.0.4 | Paieon, Inc. | IZI | Class II | 2008-11-18 |
| K082354 | STEREO NAVIGATOR ACCESSORY, STN-1000 | Naviscan Pet Systems | KPS | Class II | 2008-11-18 |
| K082581 | C-QUEST | Medx, Inc. | KPS | Class II | 2008-11-14 |
| K083018 | CENTRICITY PACS WEB DIAGNOSTIC | Ge Healthcare Dynamic Imaging Solutions | LLZ | Class II | 2008-11-14 |
| K082430 | SYNGO IMAGING XS | Siemens AG Medical Solutions | LLZ | Class II | 2008-11-14 |
| K082142 | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc., Ultrasound DI | IYN | Class II | 2008-11-13 |
| K083035 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM | Sicel Technologies, Inc. | NZT | Class II | 2008-11-13 |
| K082606 | COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS) | D3 Radiation Planning | MUJ | Class II | 2008-11-10 |
| K083160 | 1.5T ATLAS SPEEDER HEAD-NECK COIL | Quality Electrodynamics | MOS | Class II | 2008-11-07 |
| K082243 | PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS | General Medical Merate S.P.A | OWB | Class II | 2008-11-07 |
| K082627 | MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL | Minxray, Inc. | IZL | Class II | 2008-11-07 |
| K082642 | ONCENTRA RT VIEWER 1.0 | Nucletron Corporation | MUJ | Class II | 2008-11-07 |
| K082427 | SYNGO MR B17 | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2008-11-07 |
| K082706 | INFINITT CARDIOLOGY PACS | Infinitt Co., Ltd. | LLZ | Class II | 2008-11-06 |
| K082987 | HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL | Invivo | MOS | Class II | 2008-11-06 |
| K082261 | DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS | Dxrad Solutions , Ltd. | KPR | Class II | 2008-11-06 |
| K083147 | DISCOVERY MR450 | Ge Medical Systems, LLC | LNH | Class II | 2008-11-04 |
| K083095 | SONIXTOUCH ULTRASOUND SYSTEM | Ultrasonix Medical Corporation | IYN | Class II | 2008-10-31 |
| K082410 | MASTER3DS | E-Woo Technology | OAS | Class II | 2008-10-31 |
| K082530 | APPLICATORS FOR AFTERLOADING BRACHYTHERAPY | Isodose Control B.V. | JAQ | Class II | 2008-10-30 |
| K082798 | DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 | Medicatech USA | KPR | Class II | 2008-10-28 |
| K082493 | MEDICAL DISPLAY, MD205MG-1 | Nec Display Solutions , Ltd. | LLZ | Class II | 2008-10-23 |
| K083001 | M5 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2008-10-22 |
| K082221 | RAYDOSE | Raysearch Laboratories AB | MUJ | Class II | 2008-10-22 |
| K082135 | SHOWCASE | Trillium Technology, Inc. | LLZ | Class II | 2008-10-21 |
| K082458 | P3T ABDOMEN | Medrad, Inc. | JAK | Class II | 2008-10-17 |
| K083014 | ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A | Toshiba America Medical Systems, In.C | MOS | Class II | 2008-10-17 |
| K082960 | GE XTREME INJECTOR OPTION | Ge Medical Systems, LLC | JAK | Class II | 2008-10-17 |
| K082402 | OSDX HIP BMD SYSTEM | Imaging Therapeutics, Inc. | KGI | Class II | 2008-10-16 |
| K080581 | VB IMAGE VIEWER | Olympus Medical Systems Corporation | JAK | Class II | 2008-10-16 |
| K082916 | HRB-127-32 HIGH RESOLUTION BRAIN COIL | Invivo | MOS | Class II | 2008-10-15 |
| K082336 | XR-EXPRESS | New Mexico Software, Inc. | LLZ | Class II | 2008-10-15 |
| K082684 | 4D VIEWER RADIOLOGY, MODEL USWP-100A | Toshiba America Medical Systems, In.C | LLZ | Class II | 2008-10-14 |
| K082543 | SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100 | Sonocine, Inc. | IYO | Class II | 2008-10-14 |
| K082653 | CENTERING INTRALUMINAL APPLICATOR | Varian Medical Systems, Inc. | JAQ | Class II | 2008-10-10 |
| K082830 | INFX-8000H, INFINIX-I | Toshiba America Medical Systems, In.C | JAA | Class II | 2008-10-10 |
14,721 clearances in the Radiology panel. Data: openFDA.