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Radiology

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

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RecordFirmDate
DYNACT (K042646)Siemens Medical Systems, Inc.2004-10-19
IPACS CARDIO (K042781)Realtimeimage, Inc.2004-10-19
COLON CAR 1.2 (K042674)Medicsight2004-10-19
IQQA-CHEST SOFTWARE PACKAGE (K042408)Edda Technology, Inc.2004-10-08
COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY (K042605)Siemens AG Medical Solutions2004-10-08
WIDE 1MP LCD MONITOR SYSTEM (K042634)Wide Corporation2004-10-08
CLARITY FUSION (K042692)Shared P.E.T. Imaging, LLC2004-10-07
EXAM-PACS (K042647)Coactiv, LLC2004-10-07
NP-2600 SERIES HARDCOPY PRINTERS (K042232)Codonics, Inc.2004-10-05
SCANX 14 (K042397)Air Techniques, Inc.2004-10-05
G-SCAN (K042236)Esaote, S.p.A.2004-10-04
PHILIPS IU22 ULTRASOUND SYSTEM (K042540)Philips Ultrasound, Inc.2004-10-04
PRACTIX CONVENIO (K042368)Philips Medical Systems North America Co.2004-10-04
BP-SPECT V1.O (K042258)Syntermed, Inc.2004-10-04
CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION (K042525)Ge Medical Systems Information Technologies2004-10-01
LSO PET/CT HIREZ 64 (K042467)Cti Pet Systems, Inc.2004-10-01
DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D (K042361)Sedecal USA, Inc.2004-09-29
ALLURA 3D-CA, RELEASE 1 (K042334)Philips Medical Systems North America Co.2004-09-27
UBIPACS (K042507)Icm Co., Ltd.2004-09-27
KODAK COLOR MEDICAL IMAGER 1000 (K042159)Eastman Kodak Company2004-09-24
LEONARDO SYNGO CARDIOLOGY WORKSTATION (K042203)Siemens Medical Solutions USA, Inc.2004-09-24
MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL (K042342)Usa Instruments, Inc.2004-09-24
KODAK MEDICAL IMAGER 300 (K042158)Eastman Kodak Company2004-09-24
MHLX7EC TRANSDUCER (K040213)Microhelix, Inc.2004-09-22
ULTRASOUND CAPTURE SYSTEM (K042042)Heartlab, Inc.2004-09-21
XPLORER 1600 (K042041)Imaging Dynamics Company Limited2004-09-17
SCEPTREP3 PET/CT (K042428)Hitachi Medical Systems America, Inc.2004-09-17
ROBOCOUCH PATIENT SUPPORT SYSTEM (K042146)Accuray Incorporated2004-09-17
ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER (K042326)Ultrasonix Medical Corporation2004-09-16
SOMATOM SPIRIT (K042328)Siemens Medical Systems, Inc.2004-09-14
PACSPARTNER (K042311)Medical Standard Co., Ltd.2004-09-09
INTEGRADWEB MPR/MIP (K042313)Dynamic Imaging, Inc.2004-09-09
DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION (K042257)General Electric Co.2004-09-08
ISITE PACS (K042292)Stentor, Inc.2004-09-08
BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER (K042293)Philips Medical Systems (Cleveland), Inc.2004-09-08
LEKSELL GAMMAPLAN 4C WITH MULTIVIEW (K042269)Elekta Instrument AB2004-09-08
ULTRAVISUAL (K042008)Emageon Uv, Inc.2004-09-03
TARGETSCAN BIOPSY KIT (K041638)Envisioneering, LLC2004-09-02
TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM (K041639)Envisioneering, LLC2004-09-02
SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE (K042229)Siemens Medical Solution, Inc. USA2004-09-01
TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM (K041637)Envisioneering, LLC2004-09-01
BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM (K041508)Barco NV Barcoview2004-08-27
RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE (K041997)Radionics, A Division of Tyco Healthcare Group LP2004-08-27
INNOVA 4100, INNOVA 3100 (K042053)Ge Medical Systems, Inc.2004-08-26
MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY (K041929)Proxima Therapeutics, Inc.2004-08-26
11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL (K042207)Usa Instruments, Inc.2004-08-26
OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION (K041931)Ge Oec Medical Systems, Inc.2004-08-26
3.0T 8-CHANNEL CTL SPINE ARRAY (K042186)Usa Instruments, Inc.2004-08-26
FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER (K042023)Fujifilm Medical System U.S.A., Inc.2004-08-25
MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM (K041840)Medx, Inc.2004-08-20
OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM (K041932)Ge Oec Medical Systems, Inc.2004-08-18
MICROSELECTRON PDR (K041933)Nucletron Corp.2004-08-18
NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL (K042103)Mri Devices Corporation2004-08-16
DR SYSTEMS PACS, RELEASE 6.1 (K041935)Dr Systems, Inc.2004-08-16
SEEMOR 5.0 IMAGE DISPLAY PROGRAM (K041782)Areeda Assoc., Ltd.2004-08-16
I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND (K041947)Innovative Imaging, Inc.2004-08-16
CYPRESS ULTRASOUND SYSTEM (K042055)Siemens Medical Solutions USA, Inc.2004-08-16
ACUSON CV70 CARDIOVASCULAR SYSTEM (K042044)Siemens Medical Solutions USA, Inc.2004-08-13
MARK III PHASED ARRAY SHOULDER COIL (K042009)Usa Instruments, Inc.2004-08-11
NEW BRID (K041780)Medical Imaging Solutions, Inc.2004-08-11
PEDIATRIC REFERENCE DATABASE (K041266)Hologic, Inc.2004-08-11
SECURVIEW DX SOFTCOPY WORKSTATION (K041555)Hologic, Inc.2004-08-09
FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP (K041990)Fujifilm Medical System U.S.A., Inc.2004-08-06
HEMO-DOP (K041915)Dwl Elektronische Systeme GmbH2004-08-04
MODIFICATION TO: ON-BOARD IMAGER DEVICE (K041519)Varian Medical Systems, Inc.2004-08-04
ULTRABIO (K033178)Sonotech, Inc.2004-08-04
UNDECIDED (K041484)Siemens Medical Solutions USA, Inc.2004-07-30
M'ATH STD (K040686)Intelligence IN Medical Technologies2004-07-30
ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM (K041916)Aloka Co. Ltd USA2004-07-30
ALLURA XPER FD10 (K041949)Philips Medical Systems North America Co.2004-07-30
GEMINI PET/CT IMAGING SYSTEM (K041955)Philips Medical Systems (Cleveland), Inc.2004-07-29
GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR (K041922)General Electric Co.2004-07-28
MEDCOMMONS OPEN RADIOLOGY GATEWAY (K041326)Medcommons, Inc.2004-07-27
ORTHO-CMS (K041162)Medis Medical Imaging Systems BV2004-07-27
CAAS MRV (K041682)Pie Medical Imaging BV2004-07-27
PANORAMA 1.0T (K041602)Philips Medical Systems North America, Inc.2004-07-26
GE SIGNA PROFILE 6 INCH GP COIL (K041921)Ge Medical Systems, LLC2004-07-26
ECLIPSE WITH AAA (K041403)Varian Medical Systems2004-07-26
LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE (K041695)Usa Instruments, Inc.2004-07-23
PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS (K041675)Pie Medical2004-07-23
TRIMED PLAN, VERSION 2.2 (K031088)Trimed Systems, Inc.2004-07-23
GE LOGIQ 7 ULTRASOUND BT04 (K041813)Ge Medical Systems Ultrasound and Primary Care Dia2004-07-23
3DSCOPE (K041213)Direx Systems Corp.2004-07-22
IMAGENMD (K041671)Cardiovascular Imaging Technologies, LLC2004-07-22
OPTISOURCE, MODEL 1032P (K040766)International Brachytherapy S.A.2004-07-22
AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM (K041701)Agfa Corp.2004-07-22
ONCENTRA-VISIR (K041719)Nucletron Corp.2004-07-22
PATXFER RT (K040931)Brainlab AG2004-07-22
LUNG CAR 1.1 (K041807)Medicsight2004-07-22
DYNACAD V1.0 (K041286)Mri Devices Corp.2004-07-21
MAGNETOM ESPREE SYSTEM (K041112)Siemens Medical Solutions USA, Inc.2004-07-21
MODEL BBC-127 BIOPSY BREAST COIL (K041481)Mri Devices Corp.2004-07-19
MAGNETOM C! MR SYSTEM (K041111)Siemens Medical Solutions USA, Inc.2004-07-16
EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) (K041702)Ibt SA2004-07-16
MODIFICATION TO ENCOMPASS (K040896)Heartlab, Inc.2004-07-16
N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX (K040782)Image Analysis, Inc.2004-07-13
SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES (K041763)Shimadzu Corp.2004-07-13
RAPIDIACOLON (K041761)Infinitt Co., Ltd.2004-07-13
5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A) (K041737)Totoku Electric Co., Ltd.2004-07-13
LEONARDO (K040970)Siemens Medical Systems, Inc.2004-07-08
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