meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
26
Latest Decision
2004-02-26

Clearances · page 85 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K032555 3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316 Totoku Electric Co., Ltd. LLZ Class II 2004-02-26
K040326 AUTOQUANT PLUS Adac Laboratories KPS Class II 2004-02-25
K040305 VITREA2 VERSION 3.5 Vital Images, Inc. LLZ Class II 2004-02-24
K033821 KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY Eastman Kodak Company LMC Class II 2004-02-20
K040251 GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587 Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc IYN Class II 2004-02-20
K032443 DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE Shimadzu Corp. IZI Class II 2004-02-20
K034054 PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 Med-Tec,Inc. JAI Class II 2004-02-20
K033677 BRAIN PERFUSION OPTION Philips Medical Systems (Cleveland), Inc. JAK Class II 2004-02-20
K033466 COLOR LCD DISPLAY, MODEL RADIFORCE R22 Eizo Nanao Corporation LLZ Class II 2004-02-20
K040254 INTEGRIS 3D-RA, RELEASE 4.2 Philips Medical Systems North America Co. LLZ Class II 2004-02-19
K040227 QLAB QUANTIFICATION SOFTWARE Philips Ultrasound LLZ Class II 2004-02-17
K040066 SIREMOBILE C06 Siemens Medical Solutions USA, Inc. OXO Class II 2004-02-12
K032067 MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY Proxima Therapeutics, Inc. JAQ Class II 2004-02-10
K040142 ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE Adac Laboratories LLZ Class II 2004-02-06
K033470 SIMULIX EVOLUTION Nucletron Corporation KPQ Class II 2004-02-04
K033662 SYNERGY SPINE ARRAY COIL Philips Medical Systems, Inc. MOS Class II 2004-02-02
K032531 CHASE CARDIAC ANALYSIS SYSTEM Chase Medical, Inc. LLZ Class II 2004-02-02
K033825 ORTHOPACS Etrauma.Com Corp. LLZ Class II 2004-02-02
K040057 MOBILE COMPACT DIGITAL CARDIAC CAMERA Is2 Research, Inc. KPS Class II 2004-02-02
K033828 CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406 Mick Radio-Nuclear Instruments, Inc. JAQ Class II 2004-02-02
K032628 PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF United Radiology Systems, Inc. IZL Class II 2004-02-02
K040046 MINXRAY, MODEL HF120/60H POWERPLUS Minxray, Inc. IZL Class II 2004-02-02
K040141 EMORY CARDIAC TOOLBOX VERSION 2.6 Syntermed, Inc. KPS Class II 2004-01-30
K034062 CP SLEEVE AND RIVER SLEEVE Cp Medical KXK Class II 2004-01-30
K040060 SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS Siemens Medical Solutions USA, Inc. IYN Class II 2004-01-28
K040028 CA-1500 R2 Technology, Inc. LLZ Class II 2004-01-22
K032511 INTUITION IMAGE Brainlab AG LHN Class II 2004-01-21
K033507 MRJ Paramed S.R.L. LNH Class II 2004-01-20
K033956 MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC) Is2 Research, Inc. KPS Class II 2004-01-20
K032886 DIAMOND SETUP 2000 K&S Assoc., Inc. LHN Class II 2004-01-09
K033490 SPIRIT 5000 CARDIAC COIL Usa Instruments, Inc. MOS Class II 2004-01-09
K033377 FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L Fujifilm Medical System U.S.A., Inc. LMC Class II 2004-01-09
K033357 ACQSIM-MULTISLICE-CT, MODEL 453567042271 Philips Medical Systems (Cleveland), Inc. JAK Class II 2004-01-09
K034003 HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc. IYN Class II 2004-01-08
K033339 ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY Varian Medical Systems, Inc. KPQ Class II 2003-12-30
K033781 BEBIG ISOSEED I-125 Bebig Isotopen-Und Medizintechnik GmbH KXK Class II 2003-12-30
K033412 MEDICLUNG, RELEASE 1 Medicsight OEB Class II 2003-12-30
K033874 MYOLIGHT Ge Medical Systems F.I. Haifa KPS Class II 2003-12-30
K033906 PORTASCAN BLADDER SCANNER, MODEL PA00146 Mediwatch Plc IYO Class II 2003-12-24
K033001 APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4 Transphoton Corporation KPS Class II 2003-12-24
K033371 VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS Varian Medical Systems JAQ Class II 2003-12-24
K033712 MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 Sectra-Imtec AB LLZ Class II 2003-12-23
K033832 SYNGO PERFUSION-CT Siemens AG Medical Solutions JAK Class II 2003-12-23
K031281 ERGO SRS 3D Line USA, Inc. MUJ Class II 2003-12-23
K033343 TRILOGY RADIOTHERAPY DELIVERY SYSTEM Varian Medical Systems, Inc. IYE Class II 2003-12-23
K033287 EXACTRAC GATING Brainlab AG IYE Class II 2003-12-19
K033782 ALLEGRO IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc. KPS Class II 2003-12-19
K033867 GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS General Electric Co. LNH Class II 2003-12-19
K033831 SIENET COSMOS Siemens AG Medical Solutions LLZ Class II 2003-12-19
K033753 PELVIC ARRAY COIL Usa Instruments, Inc. MOS Class II 2003-12-17
K032779 MODIFICATION TO: NUCAMMA RX Is2 Research, Inc. KPS Class II 2003-12-17
K033235 GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL Usa Instruments, Inc. MOS Class II 2003-12-17
K033637 MEDICAL IMAGE DIGITIZER, MODEL 2908 Array Corp. LMA Class II 2003-12-17
K033604 TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L Pie Medical IYO Class II 2003-12-15
K032171 ACCUSOFT Direx Systems Corp. IYE Class II 2003-12-15
K033624 PACS SOFTWARE SOLUTION 2003 Canon USA, Inc. LLZ Class II 2003-12-15
K033735 VANTAGE PRO ATTENUATION CORRECTION DEVICE Adac Laboratories KPS Class II 2003-12-12
K032866 CLARITY PET Shared P.E.T. Imaging, LLC KPS Class II 2003-12-12
K033737 ALLURA XPER FD20 Philips Medical Systems North America, Inc. OWB Class II 2003-12-09
K033184 LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400 Shimadzu Corp. IZI Class II 2003-12-09
K031018 AUTOGEL PAD Rich-Mar Corp. MUI Class II 2003-12-08
K033400 SENO ADVANTAGE Ge Medical Systems W-400 LLZ Class II 2003-12-04
K033202 ADVANTAGE PADDLE Livingston Products, Inc. IZH Class II 2003-12-03
K032762 XIO RADIATION TREATMENT PLANNING SYSTEM Computerized Medical Systems, Inc. IYE Class II 2003-12-02
K031524 GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER Varian Medical Systems, Inc. JAQ Class II 2003-11-26
K031132 CONSULTIVA CASE INPUT STATION, MODEL CIS-1 Eastman Kodak Company LLZ Class II 2003-11-26
K033561 FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER Fujifilm Medical System U.S.A., Inc. MQB Class II 2003-11-26
K033292 AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 Igc-Medical Advances, Inc. MOS Class II 2003-11-26
K033013 MDIFICATION TO MEDIPRIME Algotec Systems, Ltd. LLZ Class II 2003-11-25
K033504 GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM General Electric Co. LNH Class II 2003-11-25
K033567 MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS Mri Devices Corp. MOS Class II 2003-11-25
K033431 LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ Cti Pet Systems, Inc. KPS Class II 2003-11-20
K033502 LIGHTSPEED 6.0 CT SCANNER SYSTEM Ge Medical Systems, LLC JAK Class II 2003-11-20
K033486 GE PRECISION MPI Nrt-Nordisk Rontgen Teknik A/S OWB Class II 2003-11-19
K033345 AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS Analogic Corp. KPR Class II 2003-11-19
K033353 MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES Usa Instruments, Inc. MOS Class II 2003-11-14
K033238 MOBILETTE XP AND MOBILETT XPHYBRID Siemens Medical Systems, Inc. IZL Class II 2003-11-14
K033066 XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM Xitec Holdings, LLC OXO Class II 2003-11-12
K033347 MODIFICATION TO: HI-ART SYSTEM Tomotherapy Incorporated IYE Class II 2003-11-12
K033199 COMPACT DIGITAL CARDIAC CAMERA (CDCC) Is2 Medical Systems, Inc. KPS Class II 2003-11-12
K033418 TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS Toshiba America Medical Systems, In.C JAK Class II 2003-11-10
K032475 SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION Siemens Medical Solutions USA, Inc. JAK Class II 2003-11-10
K032823 MEDICHEART, MODEL RELEASE 1 Medicsight JAK Class II 2003-11-10
K031385 ANZAI AZ-733 RESPIRATORY GATING SYSTEM Anzai Medical Co., Ltd. LHN Class II 2003-11-10
K032536 SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION Siemens Medical Solutions USA, Inc. JAK Class II 2003-11-10
K033385 DGH 55 HANDHELD PACHYMETER (PACHMATE) Dgh Technology, Inc. IYO Class II 2003-11-07
K033374 LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY Siemens AG Medical Solutions OEB Class II 2003-11-06
K033224 HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER Hologic, Inc. KGI Class II 2003-11-05
K033361 VIATRONIX V3D VASCULAR, REVISION 1.0 Viatronix, Inc. LLZ Class II 2003-11-05
K033102 MEDIC COLON MODEL, RELEASE 1 Medicsight JAK Class II 2003-11-05
K033367 TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464 Sonosite,Inc. IYN Class II 2003-11-05
K033093 ECHOCONNEX COMMUNICATOR Connexmd LLZ Class II 2003-11-05
K033209 FUKUDA DENSHI MODEL FF SONIC UF-750XT Fukuda Denshi USA, Inc. IYN Class II 2003-10-31
K032915 ADVANTAGE 4D OPTION Ge Medical Systems, LLC JAK Class II 2003-10-30
K031473 RATIONAL IMAGING PACS Intuitive Imaging Informatics, LLC LLZ Class II 2003-10-30
K032656 GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc IYN Class II 2003-10-30
K033315 SUPEROPEN 0.23T, MODEL NAM-P023A Neusoft Digital Medical Systems Co., Ltd. LNH Class II 2003-10-29
K033311 ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM Aloka Co., Ltd. IYN Class II 2003-10-29
K032748 VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE Vital Images, Inc. LLZ Class II 2003-10-29
K033088 SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 Sectra AB LLZ Class II 2003-10-29

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