meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
31
Latest Decision
1999-02-11

Clearances · page 100 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K984215 WELCH ALLYN FRONT-LINE DOC Welch Allyn, Inc. LLZ Class II 1999-02-11
K990226 GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOW Ge Medical Systems, Inc. IYO Class II 1999-02-09
K984588 PHASED ARRAY FLEXIBLE CARDIAC COIL Philips Medical Systems (Cleveland), Inc. MOS Class II 1999-02-08
K984405 ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 Intracom Corp. LMB Class I 1999-02-08
K990071 IMAGEFUSION 2.0 Radionics, Inc. MUJ Class II 1999-02-08
K984280 AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE Hitachi Medical Systems America, Inc. LNH Class II 1999-02-08
K990085 MILLENNIUM MLC -120 Varian Assoc., Inc. IYE Class II 1999-02-08
K984091 CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 Trex Medical Corp. IZH Class II 1999-02-05
K984092 PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 Trex Medical Corp. IZH Class II 1999-02-05
K984406 XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM Xitec, Inc. OXO Class II 1999-02-02
K990055 B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 Omega Medical Imaging, Inc. JAA Class II 1999-02-02
K984224 PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS Siemens Corp. LNH Class II 1999-02-02
K984257 MEDRAD PHASED ARRAY NEUROVASCULAR COIL Medrad, Inc. MOS Class II 1999-01-25
K983905 KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600 Eastman Kodak Company LMC Class II 1999-01-25
K982568 BLADDERMANAGER PCI 5000 MODEL 1002 Diagnostic Ultrasound Corp. ITX Class II 1999-01-25
K984252 IMATION TRIMATIC DIGITAL SYSTEM Imation Corp. LMA Class II 1999-01-25
K984274 MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE Hitachi Medical Systems America, Inc. LNH Class II 1999-01-25
K983678 ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE Elekta Instruments, Inc. JAI Class II 1999-01-15
K982329 VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900) Endosonics Corp. ITX Class II 1999-01-14
K983815 PACSCACHE Dome Imaging Systems, Inc. LLZ Class II 1999-01-14
K984000 STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM Surgical Navigation Technologies, Inc. LMD Class I 1999-01-12
K984159 MEDRAD QUADRATURE CTL ARRAY COIL Medrad, Inc. MOS Class II 1999-01-12
K984167 SAGE 7 GE Medical Systems LNI Class II 1999-01-12
K984307 MODIFICATION OF: RHEO DOPPLEX II Huntleigh Healthcare, Inc. IYN Class II 1999-01-12
K983902 FIELD EFFECTS MRI SYSTEM Intermagnetics General Corp. LNH Class II 1999-01-07
K983529 INSTATRAK 3000 Visualization Technology, Inc. LLZ Class II 1998-12-31
K984414 XRE COLLIMATOR WITH SPECTRAL FILTER Trex Medical Corp. IZW Class II 1998-12-30
K982791 ROCS TPS Radiation Oncology Computer Systems MUJ Class II 1998-12-30
K982549 RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC Radionics, Inc. IYE Class II 1998-12-30
K983516 TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A Toshiba America Medical Systems, In.C KPS Class II 1998-12-23
K983514 POSITRON OPTION, MODEL NSCO-050A Toshiba America Medical Systems, In.C KPS Class II 1998-12-23
K982535 INSIGHT DIAGNOSTIC IMAGING WORKSTATION Neo Imagery Technologies, Inc. LLZ Class II 1998-12-21
K983342 MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE Philips Medical Systems (Cleveland), Inc. LHN Class II 1998-12-21
K983877 PHILIPS INTEGRIS 3D RA OPTION Philips Medical Systems North America, Inc. IZI Class II 1998-12-21
K983392 DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR Data Ray LLZ Class II 1998-12-15
K981992 ELECTRON WEDGE MODEL MT-EW-1000 Med-Tec,Inc. IXI Class II 1998-12-15
K983256 ADVANTAGE WINDOWS (AW) FUSION GE Medical Systems LLZ Class II 1998-12-15
K983401 FRAMEWAVE WEB Ml Strategies, Inc. LLZ Class II 1998-12-15
K984278 MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II Hitachi Medical Systems America, Inc. MOS Class II 1998-12-11
K984111 FV-RF Philips Medical Systems (Cleveland), Inc. KPR Class II 1998-12-11
K982661 CDR - PAN MODEL 4700 Schick Technologies, Inc. MQB Class II 1998-12-11
K984272 MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000 Hitachi Medical Systems America, Inc. MOS Class II 1998-12-11
K983313 ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY Elscint, Inc. IZH Class II 1998-12-11
K983821 PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE Philips Medical Systems North America, Inc. LLZ Class II 1998-12-11
K982323 OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE Olympus America, Inc. ITX Class II 1998-12-11
K984196 MODIFICATION TO PROWESS PRO-SIM Ssgi Prowess Systems MUJ Class II 1998-12-11
K981678 STRATA, MODEL V.O.95 Rosses Medical Systems MUJ Class II 1998-12-11
K973328 INTERSOURCE International Brachytherapy S.A. KXK Class II 1998-12-10
K983724 ORCA-DX BONE DENSITOMETER Lunar Corp. KGI Class II 1998-12-08
K983564 PRODIGY TOTAL BODY SOFTWARE Lunar Corp. KGI Class II 1998-12-08
K984023 MAXVIEW DIAGNOSTIC WORKSTATION Dynamic Healthcare Technologies, Inc. LLZ Class II 1998-12-08
K983917 THERATRON ELITE Theratronics, Inc. IWB Class II 1998-12-04
K982976 ULTRASOUND WORKSTATION, UIWS-300A Toshiba America Medical Systems, In.C LLZ Class II 1998-11-24
K982536 PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE Siemens Corp. JAK Class II 1998-11-24
K982795 PHILIPS BUCKY VISION Philips Medical Systems, Inc. MQB Class II 1998-11-24
K982978 MODEL 340GE-21C QUADRATURE BRAIN COIL Medical Advances, Inc. MOS Class II 1998-11-23
K982937 MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER Victoreen, Inc. LHN Class II 1998-11-19
K982010 FACTS Philips Medical Systems (Cleveland), Inc. JAK Class II 1998-11-19
K983271 FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS Lunar Corp. KGI Class II 1998-11-18
K983262 FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS Lunar Corp. KGI Class II 1998-11-18
K983269 FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER Lunar Corp. KGI Class II 1998-11-18
K983143 MARK 5000 PHASED ARRAY SHOULDER COIL Usa Instruments, Inc. MOS Class II 1998-11-16
K982911 FORTE Adac Laboratories KPS Class II 1998-11-16
K982610 OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT) Olympus Optical, Co. ITX Class II 1998-11-16
K982994 SKULL BASE INSTATRAK SYSTEM Visualization Technology, Inc. LLZ Class II 1998-11-16
K982972 SIGNA PROFILE SMALL HEAD COIL GE Medical Systems MOS Class II 1998-11-16
K983111 XRAY VISION Apteryx, Inc. LLZ Class II 1998-11-16
K983659 PLANMED SOPHIE & PLANNED SOPHIE CLASSIC Planmed OY IZH Class II 1998-11-16
K983028 FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W Hologic, Inc. KGI Class II 1998-11-13
K981911 PROFA Duncan Hynd Associates, Ltd. IYE Class II 1998-11-12
K982840 BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING Boston Scientific Corp IYO Class II 1998-11-09
K982821 MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7 Multimedia Medical Systems, Inc. MUJ Class II 1998-11-05
K982955 SILHOUETTE VR GE Medical Systems KPR Class II 1998-11-04
K983140 CT BIOPSYVIEW Philips Medical Systems North America, Inc. JAK Class II 1998-11-04
K982857 HELAX-IMCON, VERSION 1.0 Helax AB KPQ Class II 1998-11-04
K982855 DIGIRAD 2020TC SPECT IMAGING SYSTEM Digirad Corp. KPS Class II 1998-11-04
K981556 CANON X-RAY DIGITAL CAMERA CXDI-11 Canon USA, Inc. MQB Class II 1998-11-04
K982921 MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA Medrad, Inc. MOS Class II 1998-11-03
K983621 NEEDLE GUIDE Remington Medical, Inc. IZH Class II 1998-11-03
K982769 MITRA IMAGING INC. EXHIBIT Mitra Imaging, Inc. LLZ Class II 1998-11-03
K982959 MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC Medrad, Inc. LNH Class II 1998-11-03
K981886 VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER Cook, Inc. JAQ Class II 1998-11-03
K982919 MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC Medrad, Inc. MOS Class II 1998-11-02
K980576 VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER Varian Medical Systems, Inc. JAQ Class II 1998-11-02
K982932 MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC Medrad, Inc. LNH Class II 1998-11-02
K983069 PHILIPS DUO DIAGNOST Philips Medical Systems North America, Inc. OWB Class II 1998-11-02
K982713 RT DESKTOP Elekta Oncology Systems, Ltd. IYE Class II 1998-11-02
K983447 WISE (II) IMAGE MANAGEMENT SYSTEM Sectra-Imtec AB LMB Class I 1998-10-29
K983273 XCT 2000 L PQCT BONE DENSITOMETER Medical Systems, Inc. KGI Class II 1998-10-29
K982824 X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID I.E.D., Inc. KPR Class II 1998-10-29
K982916 MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC Medrad, Inc. MOS Class II 1998-10-29
K983436 GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM Gammamed USA JAQ Class II 1998-10-29
K982834 RESTGRID PACKAGE/GYROSCAN NT Philips Medical Systems North America, Inc. LNH Class II 1998-10-29
K981528 SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYO Class II 1998-10-28
K982733 OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE The Olympus Optical Co. ITX Class II 1998-10-28
K982624 MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 Med-Tec,Inc. IYE Class II 1998-10-26
K982725 OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE Olympus America, Inc. ITX Class II 1998-10-23
K982761 JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031 Chamco, Inc. LNH Class II 1998-10-22
K980590 VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER Varian Medical Systems, Inc. JAQ Class II 1998-10-22
K980601 VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER Varian Assoc., Inc. JAQ Class II 1998-10-21

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