meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
23
Latest Decision
2005-04-18

Clearances · page 81 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K050724 SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM C.R. Bard, Inc. ITX Class II 2005-04-18
K050867 SYNGO BODY PERFUSION-CT Siemens AG JAK Class II 2005-04-14
K050663 TRAXYLOC-1 SYSTEM Traxyz Medical, Inc. IZH Class II 2005-04-08
K050692 FLXIS Philips Medical Systems North America Co. JAA Class II 2005-04-08
K050622 HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL Mri Devices Corporation MOS Class II 2005-04-08
K050704 MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING General Electric Co. KPR Class II 2005-04-08
K050602 ALTAIRE Hitachi Medical Systems America, Inc. LNH Class II 2005-04-07
K050376 PROWIN Medical Technologies International, Inc. LLZ Class II 2005-04-07
K050485 20.8-INCH(53CM) MONOCHROME LCD MONITOR MDL2110A (ME351I), (DV3MM-HB) Totoku Electric Co., Ltd. LLZ Class II 2005-04-07
K050621 NVA-127-8-A NEUROVASCULAR ARRAY COIL Mri Devices Corporation MOS Class II 2005-04-07
K050701 THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 Bionix Development Corp. IYE Class II 2005-04-01
K050510 ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 Shimadzu Medical Systems IYN Class II 2005-04-01
K050341 IMPLANT LOCATION SOFTWARE, MODEL 0.1.0 Tactile Technologies, Ltd. LLZ Class II 2005-03-29
K050667 R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE R2 Technology, Inc. LLZ Class II 2005-03-29
K050552 PACHPEN PACHYMETER, MODEL 24-5100 Accutome, Inc. IYO Class II 2005-03-28
K050514 MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS Mri Devices Corporation MOS Class II 2005-03-25
K050190 APOLLO Villa Sistemi Medicali S.P.A. KXJ Class II 2005-03-25
K050476 CORDLESS COIL Siemens Medical Solution, Inc. USA MOS Class II 2005-03-25
K050372 VISITRAK, VERSION 1, RELEASE 1 Math Resolutions, LLC IYE Class II 2005-03-25
K050509 LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I Cti Pet Systems, Inc. KPS Class II 2005-03-25
K041715 INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 Nucletron Corp. JAQ Class II 2005-03-24
K050479 4D INTEGRATED TREATMENT CONSOLE Varian Medical Systems IYE Class II 2005-03-24
K050442 MILLENNIUM MULTI-LEAF COLLIMATOR Varian Medical Systems IYE Class II 2005-03-23
K050551 VOYAGER PERSONAL IMAGING DEVICE Ardent Sound, Inc. IYO Class II 2005-03-22
K050422 550 TXT TREATMENT TABLE Siemens Medical Solutions USA, Inc. JAI Class II 2005-03-18
K050237 STARSHIELD V3 RF TRNT Odin Medical Technologies , Ltd. LNH Class II 2005-03-18
K033577 UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS Medlink Imaging KPR Class II 2005-03-18
K050366 IMAGENPRO Cardiovascular Imaging Technologies, LLC KPS Class II 2005-03-17
K050559 GE DISCOVERY VCT SYSTEM GE Medical Systems KPS Class II 2005-03-17
K042956 VISION Varian Medical Systems, Inc. IYE Class II 2005-03-11
K050489 INNOVA 2100 Ge Medical Systems, LLC OWB Class II 2005-03-11
K050458 TSX-201A AQUILION LB CT SCANNER Toshiba America Medical Systems, In.C JAK Class II 2005-03-10
K050297 SOMATOM EMOTION 16 Siemens Medical Solution, Inc. USA JAK Class II 2005-03-01
K050298 IPACS PRISM-5.0 Realtimeimage, Inc. LLZ Class II 2005-02-28
K043425 SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) Sheathing Technologies, Inc. ITX Class II 2005-02-28
K050200 MAGNETOM TRIO A TIM SYSTEM Siemens Medical Solutions USA, Inc. LNH Class II 2005-02-28
K050307 AIRIS ELITE RAPID BODY COIL Hitachi Medical Systems America, Inc. MOS Class II 2005-02-28
K050326 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 Esaote, S.p.A. IYN Class II 2005-02-28
K050196 SECTRA IDS5 WORKSTATION Sectra Imtec AB LLZ Class II 2005-02-24
K050299 HRK-123 KNEE ARRAY COIL Mri Devices Corporation MOS Class II 2005-02-24
K050380 XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A Toshiba America Medical Systems, In.C IYN Class II 2005-02-23
K050228 AGFA HEARTLAB CARDIOVASCULAR Heartlab, Inc. LLZ Class II 2005-02-18
K050199 MAGNETOM SYMPHONY A TIM SYSTEM Siemens Medical Solution LNH Class II 2005-02-18
K050363 FUKUDA DENSHI MODEL UF-850XTD Fukuda Denshi USA, Inc. IYN Class II 2005-02-17
K043379 SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 Shimadzu Corp. OXO Class II 2005-02-17
K042360 VARIAN NASOPHARYNX APPLICATOR Varian Medical Systems, Inc. JAQ Class II 2005-02-16
K050240 MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2005-02-15
K043147 ACHIEVA FAMILY Philips Medical Systems North America Co. LNH Class II 2005-02-15
K043139 USCOM 1A Uscom, Ltd. IYN Class II 2005-02-15
K050132 NEURO II-S Innovative Magnetic Resonance Imaging Systems, Inc. LNH Class II 2005-02-15
K050033 LUCION Mevisys Co., Ltd. LLZ Class II 2005-02-11
K042755 MONOCHROME LCD MONITOR, RADIFORCE G51 Eizo Nanao Corporation LLZ Class II 2005-02-10
K050151 MULTIDIAGNOST ELEVA Philips Medical Systems North America, Inc. KPR Class II 2005-02-09
K043189 SONALIS, MODEL 2000 3g Ultrasound, Inc. IYO Class II 2005-02-09
K043122 SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY Siemens AG LLZ Class II 2005-02-09
K050167 CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE Chison Medical Imaging Co., Ltd. IYO Class II 2005-02-08
K043469 SYNGO INSPACE 4D Siemens AG Medical Solutions JAK Class II 2005-02-03
K043246 BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS C.R. Bard, Inc. KXK Class II 2005-02-02
K050126 GE LOGIQ TWIN General Electric Co. IYN Class II 2005-02-02
K050092 R605 FACS COLLIMETER Omega Medical Imaging, Inc. IZW Class II 2005-01-31
K042794 BEAM MODULATOR, MODEL 4513 332 8000 Elekta , Ltd. IYE Class II 2005-01-31
K043430 20.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3MC-HB Totoku Electric Co., Ltd. LLZ Class II 2005-01-28
K050099 SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM Kontron Medical Systems Sas IYN Class II 2005-01-28
K043483 RADIN, MODEL V 3.0 Sohard AG LLZ Class II 2005-01-28
K043290 MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0 Neurognostics, Inc. LNH Class II 2005-01-28
K043596 THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 Theragenics Corp. KXK Class II 2005-01-26
K043588 MYLAB 15 / MYLAB 20, MODEL 2700 Pie Medical IYN Class II 2005-01-25
K043415 CENTRICITY PACS SYSTEM Ge Medical Systems Information Technologies LLZ Class II 2005-01-21
K043336 OPTISTRAND, MODEL 1032S Ibt SA KXK Class II 2005-01-21
K043271 R2-MRI ANALYSIS SYSTEM Inner Vision Biometrics Pty, Ltd. LNH Class II 2005-01-21
K042961 SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000 Novadaq Technologies, Inc. IZI Class II 2005-01-19
K043554 ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 B-K Medical A/S IYN Class II 2005-01-14
K043441 MIRAGE, RELEASE 5.5 Segami Corporation KPS Class II 2005-01-13
K050034 SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2005-01-13
K043524 ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 B-K Medical A/S IYN Class II 2005-01-13
K042602 REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING Ge Medical Systems, LLC MQB Class II 2005-01-13
K042861 ODYSSEY Permedics, Inc. MUJ Class II 2005-01-12
K043262 GE SIGNA EXCITE MR SURGICAL OPTION GE Healthcare LNH Class II 2005-01-12
K043559 SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) Sonosite,Inc. IYN Class II 2005-01-12
K043194 VOXAR 3D PRODUCT FAMILY Voxar Limited LLZ Class II 2005-01-11
K043563 DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYO Class II 2005-01-11
K042864 IMPLANT SCIENCES CORP, MODEL HDR-4140 Implant Sciences Corp. KXK Class II 2005-01-06
K042868 MAMMOREPORT SOFTCOPY WORKSTATION Siemens Medical Solutions USA, Inc. LLZ Class II 2005-01-06
K043535 HD11 DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc. IYN Class II 2005-01-06
K043216 CADSTREAM VERSION 4.0 Confirma, Inc. LLZ Class II 2005-01-06
K043360 IMT.LAB Pie Medical LLZ Class II 2005-01-05
K043146 HORIZON MEDICAL IMAGING Mckesson Medical Imaging Company LLZ Class II 2005-01-04
K042221 CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM Barco NV Barcoview LLZ Class II 2004-12-30
K041125 MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) Masep Med Science & Tech. Development (Shenzhen) C IWB Class II 2004-12-30
K043381 INFINIA LIGHTSPEED Ge Medical Systems F.I. Haifa KPS Class II 2004-12-23
K041078 SURGPLAN AND PANPLAN Imaging Sciences Intl., Inc. LLZ Class II 2004-12-23
K042620 SONATA 3-D IMAGING ACCESSORY, MODEL 3DS Tetrad Corp. IYO Class II 2004-12-23
K043086 SOMATOM RESPIRATORY GATING Siemens Medical Solutions USA, Inc. JAK Class II 2004-12-23
K043076 GE OEC FLUOROSTAR Ge Oec Medical Systems, Inc. OWB Class II 2004-12-22
K043455 SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM Medison Co., Ltd. IYN Class II 2004-12-21
K043452 TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM Sonosite,Inc. IYN Class II 2004-12-21
K043412 MODIFICATION TO: VIEWSTATION Impac Medical Systems, Inc. LLZ Class II 2004-12-20
K043293 MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U Acrorad Co., Ltd. KPS Class II 2004-12-17
K042863 SCENIUM Siemens Molecular Imaging, Ltd. KPS Class II 2004-12-15
K043333 VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM Vital Images, Inc. LLZ Class II 2004-12-15

14,721 clearances in the Radiology panel. Data: openFDA.