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Radiology

14,649 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
CYBERMED, INC., V-WORKS (K013878)Cybermed, Inc.2001-12-07
KODAK DIRECTVIEW TABLETOP CASSETTE (K013686)Eastman Kodak Company2001-12-07
KIMAX REMOTE VIEWING STATION (K013098)Medical Metrics, Inc.2001-12-07
NOMOS MOTORIZED CRANE II (K013036)Nomos Corp.2001-12-07
FOCAL SIM (K013112)Computerized Medical Systems, Inc.2001-12-05
ISITE RADIOLOGY (K013630)Stentor, Inc.2001-12-05
GENETRA (K013660)Radiomed Corporation2001-12-05
MILLCOMP (K011845)Math Resolutions, LLC2001-12-04
CTXA HIP; CTXA; QCT PRO CTXA HIP (K002113)Mindways Software, Inc.2001-12-04
XPLAN 2.2 WITH THE BODY SYSTEM (K013661)Radionics, A Division of Tyco Healthcare Group LP2001-12-03
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM (K010166)Imagyn Medical Technologies, Inc.2001-12-03
TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS (K013849)Tetrad Corp.2001-12-03
GIOTTO IMAGE (K012953)Medx, Inc.2001-11-30
DRYSTAR, MODEL 4500M (K012941)Agfa Corp.2001-11-29
CARDIOVASCULAR ARRAY (K013810)W. L. Gore & Associates, Inc.2001-11-27
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM (K012875)GE Medical Systems2001-11-20
HNC-63-INT NEUROVASCULAR ARRAY COIL (K013602)Mri Devices Corp.2001-11-20
EFILM VIDEO (K013631)Efilm Medical, Inc.2001-11-20
HRH-127-ALLEGRA HEAD ARRAY COIL (K013508)Mri Devices Corp.2001-11-20
SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM (K013627)Medison America, Inc.2001-11-16
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D (K013608)Toshiba America Medical Systems, In.C2001-11-15
ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (K013291)Advanced Diagnostics, Inc.2001-11-14
ADC PEDIATRIC (K012750)Agfa Corp.2001-11-14
SCANTAC MEMBRANE OR SCANTAC STRIP (K013170)Sonotech, Inc.2001-11-13
SSA-770A, APLIO ULTRASOUND SYSTEM (K013633)Toshiba America Medical Systems, In.C2001-11-13
STANDARD IMAGING IVB 1000 WELL CHAMBER (K013548)Standard Imaging, Inc.2001-11-09
IQUANTIFY, VERSION 1.0 (K011196)Insightful Corporation2001-11-08
MAROSIS PACS (K012844)Marotech, Inc.2001-11-08
LIGHTSPEED 4.0 CT SCANNER SYSTEM (K013561)GE Medical Systems2001-11-08
QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 (K013531)Impac Medical Systems, Inc.2001-11-07
GEMINI IMAGING SYSTEM (K013521)Adac Laboratories2001-11-07
SOMATOM P30 CT SYSTEMS (K013522)Siemens Medical Systems, Inc.2001-11-07
MODIFICATION TO SKYLIGHT IMAGING SYSTEM (K013496)Adac Laboratories2001-11-06
DEEP GRAY (K012563)Cortechs Labs, Inc.2001-11-02
ICONNECTION 3D (K012779)Hinnovation, Inc.2001-11-02
OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM (K012546)Sedecal USA, Inc.2001-11-02
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION (K013481)GE Medical Systems2001-11-02
MODIFICATION TO: ECAT LSO PET/CT SCANNER (K013504)Cti Pet Systems, Inc.2001-10-31
OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS (K012495)Siemens Medical Solutions USA, Inc.2001-10-31
CARDIQ FUNCTION (K013422)GE Medical Systems2001-10-30
LIFEJET VIDEO LINK (K013395)Ferrania S.P.A.2001-10-30
ULTRASOUND TRANSDUCER COVER (K011265)Advance Medical Designs, Inc.2001-10-30
ADVANCED LUNG ANALYSIS-1 (K013381)General Electric Co.2001-10-26
MODIFIED 650 MAMMOGRAPHY SYSTEM (K013290)Lorad, A Hologic Co.2001-10-24
CAAS II QVA (K012475)Pie Medical Imaging BV2001-10-24
MACHNET CAROTIDS COIL ARRAY ASSEMBLY (K012491)Machnet BV2001-10-24
ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS (K002132)Intelligent Instruments Pvt. , Ltd.2001-10-18
SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM (K012424)Shimadzu Corp.2001-10-18
WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL (K012522)National Therapy Products, Inc.2001-10-18
MOSFET AUTOSENSE, MODEL TN-RD-60 (K013279)Thomson & Nielsen Electronics, Ltd.2001-10-18
MR-GUIDE 2000 (K013150)Ultraguide , Ltd.2001-10-18
SEED SELECTRON MODEL V. 1.0 (K010032)Nucletron Corp.2001-10-17
HAC-420 HEAD ARRAY COIL (K013322)Mri Devices Corp.2001-10-16
HRH-63-8 HEAD ARRAY COIL (K013159)Mri Devices Corp.2001-10-16
LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE (K013229)Ferrania USA, Inc.2001-10-12
CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A (K013214)Toshiba America Medical Systems, In.C2001-10-05
DIASUS (K013142)Dynamic Imaging , Ltd.2001-10-05
MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 (K012227)Oncology Data Systems, Inc.2001-10-01
SOLID STATE X-RAY IMAGING DEVICES (K003238)Cares Built, Inc.2001-10-01
CTS-485 ULTRASOUND IMAGING SYSTEM (K012772)Shantou Institute of Ultrasonic Instuments2001-10-01
EXPRESSSUITE (K011049)Vidar Systems Corp.2001-10-01
DOSERIGHT (K012238)Philips Medical Systems North America Co.2001-10-01
ADC COMPACT PLUS (K013138)Agfa-Gevaert AG2001-09-28
RAPIDIA (K012290)3D Med Co., Ltd.2001-09-28
NUMARIS 4VA15A (K012202)Siemens Medical Corp.2001-09-27
SONOREAL 3D (K012084)Bio Medi Com2001-09-26
ACCUIMAGE SMARTGATE UPGRADE (K012106)Accuimage Diagnostics Corp.2001-09-25
MODIFICATION TO: QWH-420 WRIST ARRAY COIL (K013099)Mri Devices Corp.2001-09-25
GE SIGNA ASSET IMAGING OPTION (K012970)GE Medical Systems2001-09-24
AETMED IMAGE PROCESSING SOFTWARE (K012093)Aetmed, S.P.A.2001-09-21
INTRA OPERATIVE RADIATION THERAPY (K004023)Arplay Medical S.A.2001-09-21
MODIFICATION TO LR 5200 FILM RECORDER (K012010)Agfa Corp.2001-09-20
OLDELFT THORASCAN MODEL NUMBER 180T (K012165)Nucletron Corp.2001-09-19
AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K012154)Aurora Imaging Technology, Inc.2001-09-19
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER (K012775)GE Medical Systems2001-09-18
AQUARIUSNET SERVER (K012086)Terarecon,Inc.2001-09-13
MX8000 IDT CT SYSTEM (K012009)Marconi Medical Systems, Inc.2001-09-13
SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM (K012867)Medison America, Inc.2001-09-12
SA6000II DIAGNOSTIC ULTRASOUND SYSTEM (K012887)Medison America, Inc.2001-09-12
MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM (K012836)GE Medical Systems2001-09-07
MINI MULTILEAF COLLIMATOR, MODEL KMI (K011816)Mrc Systems GmbH2001-09-07
GE VISION NUCLEAR MEDICINE WORKSTATION (K012568)General Electric Co.2001-09-06
OMNIDOS (K011763)Scanditronix Medical AB2001-09-05
ACCU-SPACE ABSORBABLE SEEDING SPACERS (K010621)Cp Medical2001-09-04
EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) (K012663)Sedecal USA, Inc.2001-08-31
MBI PD-103 SL; MBI PD-103 SH (K011427)Mills Biopharmaceuticals, Inc.2001-08-31
INTERCEPT-URETHRAL MICROCOIL (K011781)Surgi-Vision, Inc.2001-08-31
SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM (K012253)Aloka Co., Ltd.2001-08-30
E-SCAN MRI SYSTEM (K012728)Biosound Esaote, Inc.2001-08-29
ELK LASER IMAGER, MODEL EL-DRY 4000 (K011949)Nishimoto Sangyo Co., Ltd.2001-08-29
VIEWSTATION (K011694)Impac Medical Systems, Inc.2001-08-29
SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM (K012080)Aloka Co., Ltd.2001-08-29
HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR (K011657)Mick Radio-Nuclear Instruments, Inc.2001-08-27
ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM (K010772)Imaging Services, Inc.2001-08-23
GE LOGIQ A100 MP, MODEL 2272413 (K012560)General Electric Co.2001-08-23
PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI (K011604)Ge Medical Systems, Inc.2001-08-22
PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM (K012379)Trex Enterprises Corp.2001-08-16
MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL (K011608)Medical Advances, Inc.2001-08-14
HNC-127 NEUROVASCULAR ARRAY COIL (K012353)Mri Devices Corp.2001-08-14
MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) (K012289)Elekta Oncology Systems, Ltd.2001-08-14
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