meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
32
Latest Decision
1989-09-01

Clearances · page 131 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K894269 CT HILIGHT ADVANTAGE GE Medical Systems JAK Class II 1989-09-01
K894021 MOBILE X-RAY UNIT Ziehm International, Inc. IZL Class II 1989-09-01
K893978 MEDISYS RECORD AND VERIFY SYSTEM Medisys, Inc. IYE Class II 1989-09-01
K892653 TOMAX ULTRASCAN Incubation Industries, Inc. IZF Class II 1989-08-28
K894230 PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735) Siemens Medical Laboratories, Inc. IYE Class II 1989-08-28
K894123 VERICORD S3 Philips Medical Systems, Inc. IYE Class II 1989-08-28
K892358 PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER Adac Laboratories KPS Class II 1989-08-23
K893837 CVIS ULTRA-SCAN ONE IMAGING CATHETER Cardiovascular Imaging Systems, Inc. IYO Class II 1989-08-22
K893398 CENTRALITE BACKPOINTER Diacor, Inc. IWE Class I 1989-08-17
K893509 GE SIGNA ADVANTAGE GE Medical Systems LNH Class II 1989-08-11
K893379 XENOS MOBILECAM Xenos Medical Systems, Inc. IYX Class I 1989-08-11
K893475 UROVIEW II Oec-Diasonics, Inc. JAA Class II 1989-08-10
K893464 VARIAN MULTILEAF COLLIMATOR Varian Assoc., Inc. IXI Class II 1989-08-10
K893644 PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER Perkins Mfg. Co. JAA Class II 1989-08-09
K892849 UNICATH A Xre Corp. IZI Class II 1989-08-09
K893750 MRT-50A MOBILE Toshiba Medical Systems LNH Class II 1989-08-09
K893820 CT SYTEC 3000 General Electric Co. JAK Class II 1989-08-07
K891131 GAMMAMED 12I Mick Radio-Nuclear Instruments, Inc. JAQ Class II 1989-08-07
K884261 PROWESS 2000 Small Systems Group, Inc. KPQ Class II 1989-08-04
K893640 SOFTWARE VERSION, D1.3 AND A1.3 FOR MAGNETOM Siemens Medical Solutions USA, Inc. LNH Class II 1989-08-02
K893826 QRSYSTEMS H.D. NUCLEAR IMAGING TABLE Qrsystems, Inc. IYZ Class I 1989-08-02
K890275 ACUSON S328 TRANSDUCER FOR FETAL CARDIAC PULSED Acuson Corp. IYO Class II 1989-07-31
K884271 ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER Acuson Corp. IYO Class II 1989-07-27
K892355 M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ Hewlett-Packard Co. IYO Class II 1989-07-24
K893637 MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM Shimadzu Medical Systems IZL Class II 1989-07-20
K893689 VISION INTEGRATED PERFORMANCE OPTION Siemens Medical Solutions USA, Inc. LNH Class II 1989-07-20
K893585 14 COLOR VIDEO DISPLAY 211-260-010 Mennen Medical, Inc. LLZ Class II 1989-07-20
K893674 RME 325R Fischer Imaging Corp. IZO Class I 1989-07-20
K892934 1 VIDEO TAPE RECORDER MODEL BK-224 H Perkins Mfg. Co. OXO Class II 1989-07-20
K893673 RMS 180 Fischer Imaging Corp. IXR Class II 1989-07-20
K892875 BIAD NUCLEAR IMAGING SYSTEM Trionix Research Laboratory, Inc. KPS Class II 1989-07-20
K893690 SUPER SPEED POTTER-BUCKY (ESO5-110 & 220) Hofmann X-Ray of America, Inc. IXQ Class II 1989-07-20
K892845 SOFTWARE RELEASE 1.3 FOR THE SL SERIES LINEAR ACCE Philips Medical Systems, Inc. IYE Class II 1989-07-20
K893681 MAMM-AIRE CP Custom Medical Products, Ltd. IZO Class I 1989-07-20
K893042 CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM Endosonics Corp. IYN Class II 1989-07-19
K890963 SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4 Esaote Biomedica Elettronica IYO Class II 1989-07-19
K893739 VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES Philips Medical Systems (Cleveland), Inc. LNH Class II 1989-07-14
K893675 VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES Philips Medical Systems (Cleveland), Inc. LNH Class II 1989-07-14
K893617 MOBILE C-ARM Acoma Medical Imaging, Inc. OXO Class II 1989-07-14
K884625 DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY Lunar KGI Class II 1989-06-23
K892860 SATURNE 41 General Electric Co. IYE Class II 1989-06-23
K890092 HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE Health Images, Inc. LNH Class II 1989-06-23
K893653 RADIOGRAPHIC CEILING TUBE SUPPORT CTS15 Fischer Imaging Corp. IYB Class I 1989-06-23
K893510 CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. EAM Class I 1989-06-23
K891760 MAGNETIC RESONANCE SYSTEM, MODEL BMT 1100,MODIFIED Bruker Medical Imaging, Inc. LNH Class II 1989-06-23
K892657 SENSIMAT Transworld X-Ray Corp. IZO Class I 1989-06-23
K893619 VISTA MR 2055 HP SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1989-06-23
K893881 ACCESS TM Diasonics, Inc. LNH Class II 1989-06-23
K893476 ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV. Andros Analyzers, Inc. JAA Class II 1989-06-23
K893521 IMLOGIX 1000 IMAGE DISPLAY SYSTEM Imlogix A Div. of Microterm LLZ Class II 1989-06-23
K893652 RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60 Fischer Imaging Corp. IYB Class I 1989-06-23
K891543 MAGNAVIEW MOBILE MRI VERSION 110 FHM Instrumentarium Imaging, Inc. LNH Class II 1989-06-23
K893452 EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM Warner-Lambert Co. IZZ Class II 1989-06-22
K891403 HUGH YOUNG II UROLOGICAL TABLE Mallinckrodt Group, Inc. IZZ Class II 1989-06-22
K891769 MAGNISCAN 5000 MR SYSTEM General Electric Co. LNH Class II 1989-06-15
K890351 ORTHORALIX SD/ORTHORALIX SD CEPH Philips Medical Systems North America, Inc. IZF Class II 1989-06-15
K891690 KODAK EKTASCAN IMAGE MANAGER Eastman Kodak Company LMB Class I 1989-06-15
K885211 RF-100 MONITOR, RF-P-2.5, RF-P-5, RF-P-7.5 PROBES Rf Design Assoc., Inc. IYN Class II 1989-06-13
K893035 OPHTHASCAN 'S' MINI-A Biophysic Medical, Inc. IYO Class II 1989-06-12
K891452 SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE Diasonics, Inc. IYO Class II 1989-06-07
K893131 DIGITAL SPOT IMAGING (DSI) Philips Medical Systems, Inc. JAA Class II 1989-06-06
K891466 ACCUSPEC THYROID UPTAKE SYSTEM Nuclear Data, Inc. IZD Class I 1989-06-06
K891238 SIEMENS TRANSESOPHAGEAL ECHO TEE TRANSDUCER Siemens Ultrasound, Inc. IYN Class II 1989-06-05
K892959 VERSION 4.2 APPLICATION SOFTWARE Resonex, Inc. LNH Class II 1989-06-01
K891453 DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582V Toshiba Medical Systems IYO Class II 1989-06-01
K885126 PHILIPS RT250 COLLIMATOR (PK8050) Perkins Mfg. Co. KQA Class II 1989-06-01
K893129 CXC FFT-1 NON-TILT STAT RADIO XRAY TAB 4 WA FL TAB Continental X-Ray Corp. IZZ Class II 1989-06-01
K891225 OPTIONAL PROBE OF CANON IOL ESTIMATOR KU-1 Canon USA, Inc. IYO Class II 1989-05-31
K892869 ANGIOTEC ZX DIGITAL IMAGE PROCESSOR Andros Analyzers, Inc. LLZ Class II 1989-05-26
K881383 ND1100 BONE DENSITY SCANNER Nuclear Data, Inc. KGI Class II 1989-05-22
K892943 MULTI PULSE POWER UNIT GENERATOR GE Medical Systems IZO Class I 1989-05-22
K891924 SCOPIX LASER IMAGER Enhanced Imaging Technologies, Inc. LMC Class II 1989-05-18
K891931 QCT-LUNG NODULE (TM) ANALYSIS PACKAGE Image Analysis, Inc. JAK Class II 1989-05-18
K890055 ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER Acuson Corp. IYN Class II 1989-05-16
K891386 CVIS ULTRA-SCAN ONE IMAGING SYSTEM Cardiovascular Imaging Systems, Inc. IYO Class II 1989-05-16
K891309 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER Advanced Technology Laboratories, Inc. IYO Class II 1989-05-16
K890969 TRANSESOPHAGEAL TRANSDUCER PEF-511SA Toshiba Medical Systems IYO Class II 1989-05-16
K885327 PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM Philips Medical Systems North America, Inc. LMB Class I 1989-05-11
K890970 TRUVEL TZ-3X X-RAY DIGITIZING SCANNER Truvel Corp. LMA Class II 1989-05-11
K891541 MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0. Diasonics, Inc. LNH Class II 1989-05-11
K892235 GE SHOULDER SURFACE COIL, CAT. #M1085AN General Electric Co. LNH Class II 1989-05-11
K891598 MODEL 2030; 3 TMJ SURFACE COIL Medical Advances, Inc. LNH Class II 1989-05-11
K890772 ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI. Boston Scientific Corp IYO Class II 1989-05-10
K884107 STEREOTACTIC BIOPSY ATTACHMENT Siemens Medical Solutions USA, Inc. IZH Class II 1989-05-05
K891485 ANGIOTEC FMX-2220 SYSTEM Andros Analyzers, Inc. LMB Class I 1989-05-05
K890519 LABSONICS MAMM-O-MATE MODEL NO. 918084-1 Laboratory Equipment Corp. IYO Class II 1989-05-03
K890784 MAMMOMAT C Siemens Medical Solutions USA, Inc. IZH Class II 1989-05-03
K891143 GENERAL ELECTRIC AMX 110 Pro-Tronics, Inc. IZL Class II 1989-05-03
K890998 QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL. Quantum Medical Systems, Inc. IYN Class II 1989-05-02
K890855 MODEL 4041; 4 ANGLED PAIR CRC SURFACE COIL Medical Advances, Inc. LNH Class II 1989-05-01
K891142 GENERAL ELECTRIC AMX II Pro-Tronics, Inc. IZL Class II 1989-05-01
K890789 GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE Philips Medical Systems North America, Inc. LNH Class II 1989-04-28
K892196 RADKOR TS10-B Radkor, Inc. IXQ Class II 1989-04-26
K892226 TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE Tecnomed, Inc. IXR Class II 1989-04-26
K884621 DIGISCAN Siemens Medical Solutions USA, Inc. LLZ Class II 1989-04-26
K883317 DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST S & S X-Ray Products, Inc. IXI Class II 1989-04-26
K891261 INTRAOPERATIVE RADIATION THERAPY DEVICES General Electric Co. LHN Class II 1989-04-26
K885020 CYTOGUIDE Philips Medical Systems North America, Inc. IZH Class II 1989-04-26
K891293 SLS SIMULATOR (MODELS SLS-9 AND SLS-14) Philips Medical Systems North America, Inc. KPQ Class II 1989-04-20
K884598 SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 Shimadzu Precision Instruments, Inc. JAA Class II 1989-04-20

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