meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
28
Latest Decision
2002-08-12

Clearances · page 90 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K021583 PATXFER Brainlab AG LLZ Class II 2002-08-12
K022428 QUANTITATIVE BLOOD POOL SPECT (QBS) Adac Laboratories LLZ Class II 2002-08-06
K013999 LODOX, MODEL BASELINE Lodox Systems (Pty), Ltd. JAK Class II 2002-08-06
K022240 MOBILE MILLENNIUM MG SYSTEM Ge Medical Systems, Inc. KPS Class II 2002-08-06
K022400 SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM Toshiba America Medical Systems, In.C IYN Class II 2002-08-06
K020150 CRC-15BT Capintec, Inc. KPT Class II 2002-08-02
K022310 ADVANTAGE WINDOWS X-RAY/MR FUSION Ge Medical Systems, Inc. LLZ Class II 2002-08-01
K022303 PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER Philips Ultrasound, Inc. IYN Class II 2002-07-30
K021780 ADVANTAGE SIM 6.0 General Electric Medical Systems KPQ Class II 2002-07-29
K020337 READI-STRAND; MODEL PSSTRAND Worldwide Medical Technologies, LLC KXK Class II 2002-07-29
K021330 MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL Usa Instruments, Inc. MOS Class II 2002-07-25
K021236 SURGERY AND ACCESSORIES Camtronics, Ltd. LLZ Class II 2002-07-17
K022013 LUNGCARE CT SOFTWARE PACKAGE Siemens Medical Solutions USA, Inc. JAK Class II 2002-07-16
K021311 SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL Cp Medical KXK Class II 2002-07-13
K022109 EIZO, MODEL FC-2091 Eizo Nanao Corporation LLZ Class II 2002-07-12
K022001 MPOWER, MODEL 712 SERIES Positron Corp. KPS Class II 2002-07-12
K021191 AUTOALIGN Cortechs Labs, Inc. LLZ Class II 2002-07-12
K020073 MEDICAL ADMINISTRATOR Barco N.V. LLZ Class II 2002-07-12
K020668 ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124 Aloka Co., Ltd. IYO Class II 2002-07-10
K021903 KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE Eastman Kodak Company IXA Class II 2002-07-10
K022050 CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI) Toshiba America Medical Systems, In.C JAK Class II 2002-07-09
K021497 CYPRESS ULTRASOUND SYSTEM Acuson Corp. IYN Class II 2002-07-09
K010065 CRANIAL STEREOTACTIC EQUIPMENT Arplay Medical S.A. IYE Class II 2002-07-02
K021829 MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM Eastman Kodak Company MQB Class II 2002-07-02
K021124 ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER Wfr/Aquaplast Corp. IYE Class II 2002-07-02
K013689 RE-ENTRANT CHAMBER Sun Nuclear Corp. KPT Class II 2002-07-02
K021314 SCEPTRE-VS Hitachi Medical Systems America, Inc. LLZ Class II 2002-07-02
K021984 PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT Inceptio Medical Technologies, LC IYN Class II 2002-07-02
K021966 Q LAB SOFTWARE Advanced Technology Laboratories, Inc. LLZ Class II 2002-07-02
K021099 REX, VERSION 1.0 Pointdx, Inc. LLZ Class II 2002-06-27
K021141 MILLENNIUM 5000 MEUROVASCULAR COIL Usa Instruments, Inc. MOS Class II 2002-06-27
K021683 CINESCAN S Quantel Medical IYO Class II 2002-06-21
K021787 VISUCAM Carl Zeiss Ophthalmic Systems, Inc. NFF Class I 2002-06-21
K021016 AMX-4 PLUS MOBILE X-RAY SYSTEM GE Medical Systems IZL Class II 2002-06-17
K021823 CARDIOSPECT D90/CARDIO CAM Nuclear Cardiology Systems, Inc. KPS Class II 2002-06-17
K020991 SYNGO MR 2002B Siemens Medical Solutions USA, Inc. LNH Class II 2002-06-13
K021113 MAMMOPATH Fischer Imaging Corp. MWP Class II 2002-06-13
K020630 ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER Ultrasonix Medical Corporation IYN Class II 2002-06-13
K021656 HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 Nuclear Diagnostics KPS Class II 2002-06-13
K021433 MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL Medical Advances, Inc. MOS Class II 2002-06-13
K021570 HNC-127-TRIO NEUROVASCULAR ARRAY COIL Mri Devices Corp. MOS Class II 2002-06-12
K021575 OBC-127 BREAST ARRAY COIL Mri Devices Corp. MOS Class II 2002-06-12
K021527 SECTRA OSTEOPOROSIS PACKAGE Sectra-Imtec AB KGI Class II 2002-06-07
K020971 DCM 2.0 Mds Nordion AB MUJ Class II 2002-06-06
K021463 MODEL 1133 IVD PC VERSION Sun Nuclear Corp. IYE Class II 2002-06-06
K021021 MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS Siemens Medical Solutions USA, Inc. JAA Class II 2002-06-06
K020860 M3 (MICRO-MULTILEAF COLLIMATOR) Brainlab AG IYE Class II 2002-06-06
K021072 FILMSAVER, NT VERSION 5.03 American Medical Resources, Ltd. (Amr) LLZ Class II 2002-06-06
K020850 GPF-29 GENERAL PURPOSE COIL SET Mri Devices Corp. MOS Class II 2002-06-06
K013902 U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000 U-Systems, Inc. IYN Class II 2002-06-05
K021669 PHYSICIAN'S DESKTOP REVIEW Adac Laboratories LLZ Class II 2002-06-05
K021628 SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES) Sonosite,Inc. IYN Class II 2002-05-31
K020643 EZ-SCOPE AN & EZ-SCOPE AN LITE Health Policy Resorters Group, LLC IYX Class I 2002-05-28
K021286 MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES Nucletron Corp. JAQ Class II 2002-05-23
K021491 HISPEED DUAL Ge Medical Systems, Inc. JAK Class II 2002-05-22
K021268 ECLIPSE, HELIOS OPTION Varian Medical Systems, Inc. MUJ Class II 2002-05-22
K021331 DEXACARE G4 Osteometer Meditech, Inc. KGI Class II 2002-05-21
K013897 SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW Bio-Scan S.A MQB Class II 2002-05-21
K020993 ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB) Magna-Lab, Inc. MOS Class II 2002-05-21
K021262 MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL Usa Instruments, Inc. MOS Class II 2002-05-21
K020790 INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL Surgi-Vision, Inc. MOS Class II 2002-05-21
K021343 ISOSEEDS I-125 Bebig Isotopen-Und Medizintechnik GmbH KXK Class II 2002-05-20
K020956 VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA Microtek Medical, Inc. MUI Class II 2002-05-16
K021132 UNI-PATCH ULTRASOUND COUPLING GEL The Ludlow Company LP MUI Class II 2002-05-15
K013886 AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) Advanced Diagnostics, Inc. NCS Class II 2002-05-10
K020449 CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM Cardionow, Inc. LLZ Class II 2002-05-10
K021054 CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER Codonics, Inc. LMC Class II 2002-05-09
K020561 SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN Tomtec Imaging Systems GmbH IYO Class II 2002-05-09
K011690 MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY Proxima Therapeutics, Inc. JAQ Class II 2002-05-06
K020876 ECHOSCAN, MODEL US-1800 Nidek, Inc. IYO Class II 2002-05-03
K021204 OLYMPUS BF TYPE UM40 Olympus Optical Co., Ltd. PSV Class II 2002-05-01
K020546 FUSION 7D Mirada Solutions , Ltd. LLZ Class II 2002-04-26
K014168 AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION) Biosound Esaote, Inc. IYN Class II 2002-04-25
K020268 ISAAC 1.5 T MR SYSTEM Chi, Inc. LNH Class II 2002-04-25
K020601 FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL Odin Medical Technologies , Ltd. MOS Class II 2002-04-24
K020289 MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS Machnet BV LNH Class II 2002-04-24
K020495 INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL Surgi-Vision, Inc. MOS Class II 2002-04-23
K020300 NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS) Syntermed, Inc. KPS Class II 2002-04-23
K020294 MOTION TRACKING Accuray, Inc. IYE Class II 2002-04-22
K020112 50S TRINGA ULTRASOUND IMAGING SYSTEM Pie Medical IYO Class II 2002-04-19
K021049 OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems OWB Class II 2002-04-17
K020995 EFILM WORKSTATION WITH MODULES Efilm Medical, Inc. LLZ Class II 2002-04-12
K020151 UD-1000 ULTRASONIC A/B SCANNER Tomey Corp. USA IYO Class II 2002-04-10
K012803 AL-2000 COMBINED BIOMETER AND PACHYMETER Tomey Corp. IYO Class II 2002-04-08
K013848 U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 U-Systems, Inc. IYN Class II 2002-04-08
K020176 HDR MIAMI APPLICATOR Mick Radio-Nuclear Instruments, Inc. JAQ Class II 2002-04-08
K020789 GE VIVID 3 EXPERT; GE VIVID 3 PRO General Electric Co. IYN Class II 2002-04-04
K020058 MEDICAL LE Barco N.V. LLZ Class II 2002-04-04
K013088 ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS Echotech 3D Imaging Systems, Inc. IYO Class II 2002-04-04
K020913 CT-C3000 SPIRAL CT SCANNER SYSTEM Neusoft Digital Medical Systems Co., Ltd. JAK Class II 2002-04-03
K020061 IMAGEDESK Barco N.V. LLZ Class II 2002-04-03
K020059 MFCD 118I Barco N.V. LLZ Class II 2002-04-03
K020929 SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 GE Medical Systems JAK Class II 2002-04-03
K013363 CROSSPOINT TRANSACCESS CATHETER Trans Vascular Incorporated ITX Class II 2002-04-02
K020796 CARD IQ ANALYSIS II GE Medical Systems JAK Class II 2002-03-26
K004022 M3 (MIRCO-MULTILEAF COLLIMATOR Brainlab AG IYE Class II 2002-03-26
K013426 MOONRAY MOBILE C-ARM Simad S.R.L. OXO Class II 2002-03-26
K014240 PRONTO Hitachi Medical Systems America, Inc. JAK Class II 2002-03-22
K020635 KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976 Eastman Kodak Company MQB Class II 2002-03-21
K020055 PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION Philips Medical Systems JAA Class II 2002-03-15

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