meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
32
Latest Decision
2004-12-15

Clearances · page 82 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K043350 MISTAR, MODEL V3.2 Apollo Medical Imaging Technology Pty. , Ltd. LLZ Class II 2004-12-15
K043087 SOMATOM CARE CONTRAST CT Siemens Medical Solutions USA, Inc. JAK Class II 2004-12-15
K042386 DIRECT DIGITIZER, REGIUS MODEL 190 Konica Minolta Medical & Graphic, Inc. MQB Class II 2004-12-15
K043134 METRX WORKSTATION Medical Metrx Solutions, Inc. LLZ Class II 2004-12-13
K043062 MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM Source-Ray, Inc. IZL Class II 2004-12-13
K043278 TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES Teratech Corp. ITX Class II 2004-12-13
K043287 PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 Micromedical Devices, Inc. IYO Class II 2004-12-10
K043117 BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER Best Medical International, Inc. KXK Class II 2004-12-09
K043275 OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER Olympus Medical Systems Corporation IYO Class II 2004-12-09
K043030 MAGNETOM C! MR SYSTEM Siemens Medical Solutions LNH Class II 2004-12-09
K042840 SHIMADZU COLLIMATOR R-20J Shimadzu Corp. IZX Class II 2004-12-03
K043196 ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM Aloka Co., Ltd. IYN Class II 2004-11-30
K042353 AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS National Display Systems LLZ Class II 2004-11-24
K043112 GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM General Electric Co. LNH Class II 2004-11-24
K042995 X-LEONARDO Siemens Medical Solutions USA, Inc. LLZ Class II 2004-11-24
K042133 DRY LASER IMAGER, MODEL DRYPRO MODEL 793 Konica Minolta Medical & Graphic, Inc. LMC Class II 2004-11-24
K042942 MGP 15 DICOM THEATER Barco NV Barcoview LLZ Class II 2004-11-22
K042662 NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM Barco NV Barcoview LLZ Class II 2004-11-22
K042746 PET-DOSE Comecer S.R.L. KPT Class II 2004-11-22
K043025 SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 Analogic Corp. KPR Class II 2004-11-19
K043097 3VISEON 3Mensio Medical Imaging BV LLZ Class II 2004-11-19
K042671 PLANMED SOPHIE NUANCE CLASSIC Planmed OY IZH Class II 2004-11-19
K042697 SECOND LOOK VIEWER Icad, Inc. LLZ Class II 2004-11-19
K042894 IMALUX NIRIS IMAGING SYSTEM Imalux Corporation NQQ Class II 2004-11-19
K042660 NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM Barco NV Barcoview LLZ Class II 2004-11-19
K042661 NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM Barco NV Barcoview LLZ Class II 2004-11-19
K043002 SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR Sedecal., Sa. IZL Class II 2004-11-18
K042694 ADVANCED LUNG ANALYSIS II GE Medical Systems OEB Class II 2004-11-18
K032315 IOP8 INTRA OPERATIVE PROBE Huntleigh Healthcare, Inc. ITX Class II 2004-11-18
K043111 PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A Toshiba America Medical Systems, In.C JAK Class II 2004-11-18
K042786 BEST MODEL # 81-01 SERIES IR-192 SOURCES Best Medical International, Inc. KXK Class II 2004-11-18
K042876 URS LP DIGITAL, MILLENNIUM, RADPRO Sedecal., Sa. KPR Class II 2004-11-18
K043078 NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A Toshiba America Medical Systems, In.C IYO Class II 2004-11-17
K043016 SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2004-11-16
K041937 RESTITU Resonant Medical, Inc. IYE Class II 2004-11-16
K042733 STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM Standard Imaging, Inc. LHO Class I 2004-11-15
K042718 13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA Siemens Medi Cal Solutions, Inc. MOS Class II 2004-11-12
K042250 SENSATOUCH Aluna Management Co., Ltd. IYO Class II 2004-11-12
K042188 VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM Volcano Therapeutics, Inc. IYO Class II 2004-11-10
K042816 TRAUMACAD 1.2 Orthocrat, Ltd. LLZ Class II 2004-11-10
K042752 ACCUPACH V Accutome Ultrasound, Inc. IYO Class II 2004-11-10
K041818 SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020 Boston Scientific Corp ITX Class II 2004-11-10
K042935 GEMINI GXL Philips Medical Systems (Cleveland), Inc. KPS Class II 2004-11-09
K042700 IMAGE MEDICAL ACQUISITION STATION (IMAS) Erad Imagemedical Corp. LLZ Class II 2004-11-08
K042438 SUPERDIMENSION/BRONCHUS Superdimension, Ltd. JAK Class II 2004-11-08
K042619 ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT Sonotech, Inc. MUI Class II 2004-11-05
K042617 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA Siemens Medical Solutions USA, Inc. MOS Class II 2004-11-05
K042880 JETSTREAM WORKSPACE Adac Laboratories KPS Class II 2004-11-03
K042739 HI-ART SYSTEM Tomotherapy Incorporated MUJ Class II 2004-11-03
K042586 BEST BREAST BRACHYTHERAPY APPLICATOR Best Medical International, Inc. JAQ Class II 2004-11-03
K042948 I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM Wandong Medical LNH Class II 2004-11-03
K042844 GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL Ge Medical Systems, Inc. MOS Class II 2004-11-03
K042866 AMX5 AND AMX5D MOBILE X-RAY SYSTEMS Ge Healthcare Technologies IZL Class II 2004-11-02
K042867 PHILIPS ORTHOPAEDIC APPLICATIONS Philips Medical Systems North America, Inc. LLZ Class II 2004-11-02
K042480 INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS Hologic, Inc. KGI Class II 2004-10-29
K042903 AUTOSPECS Adac Laboratories KPS Class II 2004-10-29
K042839 C-PET PLUS IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc. KPS Class II 2004-10-29
K042720 ON-BOARD IMAGER DEVICE Varian Medical Systems IYE Class II 2004-10-29
K042095 MAMMOTEST Fischer Imaging Corp. IZH Class II 2004-10-29
K042793 ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) Siemens Medi Cal Solutions, Inc. OWB Class II 2004-10-29
K042832 SIENET COSMOS (VERSION V15A) Siemens AG Medical Solutions LLZ Class II 2004-10-28
K042831 ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) Reichert, Inc. IYO Class II 2004-10-28
K042833 SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS Siemens Medical Solutions USA, Inc. IYO Class II 2004-10-27
K042698 UNFORS PATIENT SKIN DOSIMETER (PSD) Unfors, Inc. JAA Class II 2004-10-22
K042821 DIGITAL DETECTOR, MODEL GR17 Anrad Corp. MQB Class II 2004-10-22
K042212 IMPLANTMASTER I-Dent LLZ Class II 2004-10-21
K042779 RADIOTHERAPY SOLUTION BASED ON CR Agfa Corp. IXK Class II 2004-10-21
K042383 RSA-CMS Medis Medical Imaging Systems BV LLZ Class II 2004-10-20
K042484 NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER Nai Technology Products LMA Class II 2004-10-20
K042369 SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000 Sonoscape Company Limited IYN Class II 2004-10-20
K042770 MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2004-10-20
K042781 IPACS CARDIO Realtimeimage, Inc. LLZ Class II 2004-10-19
K042445 SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT Bard Access Systems, Inc. ITX Class II 2004-10-19
K042646 DYNACT Siemens Medical Systems, Inc. IZI Class II 2004-10-19
K042674 COLON CAR 1.2 Medicsight NWE Class II 2004-10-19
K042634 WIDE 1MP LCD MONITOR SYSTEM Wide Corporation LLZ Class II 2004-10-08
K042605 COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY Siemens AG Medical Solutions NWE Class II 2004-10-08
K042408 IQQA-CHEST SOFTWARE PACKAGE Edda Technology, Inc. OMJ Class II 2004-10-08
K042692 CLARITY FUSION Shared P.E.T. Imaging, LLC LLZ Class II 2004-10-07
K042647 EXAM-PACS Coactiv, LLC LLZ Class II 2004-10-07
K042397 SCANX 14 Air Techniques, Inc. MQB Class II 2004-10-05
K042232 NP-2600 SERIES HARDCOPY PRINTERS Codonics, Inc. LMC Class II 2004-10-05
K042540 PHILIPS IU22 ULTRASOUND SYSTEM Philips Ultrasound, Inc. IYO Class II 2004-10-04
K042236 G-SCAN Esaote, S.p.A. LNH Class II 2004-10-04
K042258 BP-SPECT V1.O Syntermed, Inc. KPS Class II 2004-10-04
K042368 PRACTIX CONVENIO Philips Medical Systems North America Co. IZL Class II 2004-10-04
K042467 LSO PET/CT HIREZ 64 Cti Pet Systems, Inc. KPS Class II 2004-10-01
K042525 CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION Ge Medical Systems Information Technologies LLZ Class II 2004-10-01
K042361 DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D Sedecal USA, Inc. IZL Class II 2004-09-29
K042507 UBIPACS Icm Co., Ltd. LLZ Class II 2004-09-27
K042334 ALLURA 3D-CA, RELEASE 1 Philips Medical Systems North America Co. LLZ Class II 2004-09-27
K042203 LEONARDO SYNGO CARDIOLOGY WORKSTATION Siemens Medical Solutions USA, Inc. LLZ Class II 2004-09-24
K042159 KODAK COLOR MEDICAL IMAGER 1000 Eastman Kodak Company LMC Class II 2004-09-24
K042158 KODAK MEDICAL IMAGER 300 Eastman Kodak Company LMC Class II 2004-09-24
K042342 MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL Usa Instruments, Inc. MOS Class II 2004-09-24
K040213 MHLX7EC TRANSDUCER Microhelix, Inc. ITX Class II 2004-09-22
K042042 ULTRASOUND CAPTURE SYSTEM Heartlab, Inc. LLZ Class II 2004-09-21
K042146 ROBOCOUCH PATIENT SUPPORT SYSTEM Accuray Incorporated JAI Class II 2004-09-17
K042428 SCEPTREP3 PET/CT Hitachi Medical Systems America, Inc. KPS Class II 2004-09-17
K042041 XPLORER 1600 Imaging Dynamics Company Limited MQB Class II 2004-09-17

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