meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
31
Latest Decision
1988-08-19

Clearances · page 134 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K882162 NIDEK US-3000 Nidek, Inc. IYO Class II 1988-08-19
K882175 HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP Eigen JAA Class II 1988-08-19
K882959 ENDOVAGINAL PROBE, SMS-510VA Toshiba Medical Systems IYO Class II 1988-08-18
K883312 L-F/KODAK FLEXIBLE GRID CASSETTE Mallinckrodt Group, Inc. IXA Class II 1988-08-16
K882581 CT MAX 640 #B7940 JA/JE General Electric Co. JAK Class II 1988-08-15
K880525 3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF Fischer Imaging Corp. IZO Class I 1988-08-15
K882022 TOMOSCAN LX COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc. JAK Class II 1988-08-15
K882805 CILCO VILLASENOR PACHYMETER Coopervision-Cilco IYO Class II 1988-08-12
K882176 VTR-12 Eigen JAA Class II 1988-08-11
K882205 VIEWPOINT Adac Laboratories LLZ Class II 1988-08-11
K881665 OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR Omnitron Intl., Inc. JAQ Class II 1988-08-11
K881017 DPS-33,000 WITH CENTOR OPTION Adac Laboratories LLZ Class II 1988-08-11
K882519 X-RAY MARKER Karlin Technology, Inc. JAC Class I 1988-08-09
K882096 SCOPIX VIDEO IMAGER Agfa-Gevaert, Inc. LMC Class II 1988-08-09
K880200 EXL-14 MEDICAL LINEAR ACCELERATOR Mitsubishi Intl. Corp. IYE Class II 1988-08-04
K881886 MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L U.S. Imaging, Inc. IZO Class I 1988-08-04
K882483 FTI 200 MEDICAL THERMAL IMAGER Fujifilm Medical System U.S.A., Inc. LMC Class II 1988-08-04
K873452 MODIFIED MODEL SSD-650 SYSTEM Ge Medical Systems Information Technologies IYO Class II 1988-07-28
K875088 XENON CT Siemens Medical Solutions USA, Inc. JAK Class II 1988-07-26
K874943 SONAR-AID(R) ULTRASOUND STANDOFF PAD Geistlich-Pharma ITX Class II 1988-07-25
K882492 A.X.T. SPOTFILM DEVICE Applied X-Ray Technologies, Inc. IXL Class II 1988-07-21
K874192 MULTIPURPOSE TRANSDUCER RANGE Pie Data Medical BV IYO Class II 1988-07-19
K881812 AERO-MIST NEBULIZER Cadema Medical Products, Inc. IYT Class II 1988-07-18
K881589 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 Continental X-Ray Corp. IXL Class II 1988-07-18
K874473 ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM Adac Laboratories JWM Class II 1988-07-18
K882312 MODEL 3000 NUCLEAR CAMERA Ohio Imaging, Inc. IYX Class I 1988-07-14
K880352 MTX GENERATOR Philips Medical Systems (Cleveland), Inc. KPR Class II 1988-07-14
K882563 RADKOR, CST-18 Radkor, Inc. IYB Class I 1988-07-08
K881387 X-RAY GENERATING SYSTEM, TF 800 Absolute X-Ray Corp. IZO Class I 1988-07-08
K881386 X-RAY GENERATING SYSTEM TF 1000 General Medical Merate S.P.A IZO Class I 1988-07-08
K875357 BIOPSY FIXATION UNIT-TYPE UA 0997 Bruel & Kjaer Industri A/S IYO Class II 1988-07-01
K881795 SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K Shimadzu Precision Instruments, Inc. IZO Class I 1988-07-01
K875198 DIGITAL NUCLEAR IMAGING SYSTEM Medasys, Inc. IYX Class I 1988-07-01
K874910 SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200 Shimadzu Precision Instruments, Inc. IZI Class II 1988-07-01
K882323 MEICOR X-RAY TUBE, MODELS MC1000, MC1500, MC2000 Meicor, Inc. ITY Class I 1988-06-30
K882184 HR-1000 W/SUFFIXES (B,C OR D) Eigen LMB Class I 1988-06-28
K874211 EUB-450 DIAGNOSTIC ULTRASOUND DEVICE Hitachi Medical Corp. of America IYO Class II 1988-06-23
K881605 BIOPSY GUIDE Teknar, Inc. IYO Class II 1988-06-21
K874028 ACUSON S328 TRANSDUCER Acuson Computed Sonography IYO Class II 1988-06-21
K882320 KODAK EKTASCAN LASER PRINTER ADAPTER, MODEL M6/M8 Eastman Kodak Company IXW Class II 1988-06-16
K881506 MAMEX DC MAG MG12 Orion Corp. IZH Class II 1988-06-10
K881505 MAMEX DC MG11 Orion Corp. IZH Class II 1988-06-10
K880839 AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM Phoenix Imaging IYO Class II 1988-06-10
K880580 EXTENDED MULTIPURPOSE TRANSDUCER RANGE Pie Medical USA BV IYO Class II 1988-06-08
K873296 DPX BONE DENSITOMETER Lunar Radiation Corp. KGI Class II 1988-06-06
K880982 ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY Orion Corporation Soredex KPR Class II 1988-06-06
K882019 SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE General Electric Co. IXR Class II 1988-05-31
K881882 SENOGRAPHE 600T AND 600TS SENIX HF General Electric Co. IZH Class II 1988-05-25
K881688 DTV-4114 FLUOROSCOPIC TELEVISION CAMERA Adac Laboratories IZJ Class II 1988-05-18
K875370 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX Shimadzu Precision Instruments, Inc. JAK Class II 1988-05-18
K881208 PROBE SHEATH FOR ADMS ULTRASOUND PROBE Advanced Diagnostic Medical Systems, Inc. IYO Class II 1988-05-16
K875251 ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE Philips Medical Systems (Cleveland), Inc. IYO Class II 1988-05-11
K880519 SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 650 Fischer Imaging Corp. IZO Class I 1988-05-04
K880524 THREE PHASE DIAGNOSTIC X-RAY GENERATOR MICRO-X 100 Fischer Imaging Corp. IZO Class I 1988-05-04
K880521 SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650 Fischer Imaging Corp. IZO Class I 1988-05-04
K880522 THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80 Fischer Imaging Corp. IZO Class I 1988-05-04
K880523 THREE PHASE, DIAGNOSTIC GENERATOR MICRO-X 75 Fischer Imaging Corp. IZO Class I 1988-05-04
K880531 MAMMOGRAPHIC X-RAY SYSTEM ATHENA Fischer Imaging Corp. IZH Class II 1988-05-02
K874363 ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI. Acuson Computed Sonography IYO Class II 1988-05-02
K874558 SL SERIES, SL 15, 18, 20 & 25 Philips Medical Systems, Inc. IYE Class II 1988-05-02
K873398 EXL-22DP X-RAY RADIATION THERAPY SYSTEM Mitsubishi Intl. Corp. IYE Class II 1988-04-29
K881591 A2J MZ 45 LASER LIGHT FOR POSITIONING A2j, Inc. IWX Class I 1988-04-27
K881028 7.5 MHZ ENDORECTAL PROBE Philips Ultrasound, Inc. IYO Class II 1988-04-27
K874684 TC2-64B TRANSCRANIAL DOPPLER Carolina Medical Electronics IYO Class II 1988-04-25
K874685 TRANS-SCAN 3-D TRANSCRANIAL DOPPLER Carolina Medical Electronics IYO Class II 1988-04-25
K880981 A2J MZ 44 B TYPE A2j, Inc. IWE Class I 1988-04-22
K873702 REI-38 RADIOGRAPHIC TABLE Radiological Engineering, Inc. IXQ Class II 1988-04-22
K880714 DIASONICS QT ENDORECTAL 7.5 MHZ PROBE Diasonics, Inc. IYO Class II 1988-04-21
K874548 SIM 4000C Ote-Biomedica Elettronica S.P.A IYO Class II 1988-04-18
K874683 THE ESI-2000 ULTRASOUND UNIT Elscint, Inc. IYO Class II 1988-04-18
K875128 TRANS/R NEEDLE GUIDE CIVCO Medical Instruments Co., Inc. IYO Class II 1988-04-15
K875240 TRANS/V NEEDLE GUIDE CIVCO Medical Instruments Co., Inc. IYO Class II 1988-04-15
K875236 TRANS/P NEEDLE GUIDE CIVCO Medical Instruments Co., Inc. IYO Class II 1988-04-15
K875241 CIVCO SEED IMPLANT NEEDLE GUIDE CIVCO Medical Instruments Co., Inc. IYO Class II 1988-04-14
K880659 TEKNAR PROSCAN ACCESSORY PROBE Teknar, Inc. IYO Class II 1988-04-14
K881248 KODAK AUTOMATIC FILM FEEDER, MODEL 11 Eastman Kodak Company IXW Class II 1988-04-12
K880047 HUESTIS COMPU-FORMER Huestis Machine Corp. IXI Class II 1988-04-11
K871868 VENTI-SCAN II Atomic Products Corp. IYT Class II 1988-04-11
K873845 SIM 4000I Ote-Biomedica Elettronica S.P.A IYO Class II 1988-04-07
K880219 TRANSRECTAL PROBE BD65S-TR Elscint, Inc. IYO Class II 1988-03-31
K880822 PICS-2000 Philips Medical Systems, Inc. JAK Class II 1988-03-28
K880965 SOMATOM PLUS Siemens Medical Solutions USA, Inc. JAK Class II 1988-03-28
K880532 SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX 350 Fischer Imaging Corp. IZO Class I 1988-03-28
K873937 SDR 3500 (PHILIPS PLATINUM +) Philips Ultrasound, Inc. IYO Class II 1988-03-23
K880563 3M XP515 X-RAY FILM PROCESSOR 3M Company IXW Class II 1988-03-21
K880564 3M XP 505 X-RAY FILM PROCESSOR 3M Company IXW Class II 1988-03-21
K880565 3M TRIMATIC M MODULAR SYSTEM AND ACCESSORIES 3M Company IXW Class II 1988-03-21
K880905 MAMMOGRAPHY MOVING GRID BUCKY Custom Medical Products, Ltd. IZH Class II 1988-03-21
K880081 VISION CARE/PHAKOSYSTEMS ECHOPACH Phakosystems, Inc. IYO Class II 1988-03-15
K880065 NIDEK UP-2000 Nidek, Inc. IYO Class II 1988-03-15
K880169 CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION Cemax, Inc. LLZ Class II 1988-03-09
K880518 MOBILE C-ARM OMNI 325 Fischer Imaging Corp. OXO Class II 1988-03-09
K880530 CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX Fischer Imaging Corp. IYB Class I 1988-03-03
K880529 CEILING MOUNTED TILTING TABLE TANGENT III Fischer Imaging Corp. IXR Class II 1988-03-03
K874946 SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60 Shimadzu Precision Instruments, Inc. IZO Class I 1988-03-03
K873159 COMBISON(R) 310A REAL TIME ULTRASOUND SCANNER Cone Instruments, Inc. IYO Class II 1988-03-01
K880272 CAL/RAD UPGRADE MODEL 1030 Sun Nuclear Corp. KPT Class II 1988-02-29
K880050 EDEC 60R Electromed Intl., Ltd. IZO Class I 1988-02-29
K880528 OVERHEAD TUBE MOUNT CASCADE II Fischer Imaging Corp. IYB Class I 1988-02-29
K880527 CEILING MOUNTED FLUOROSCOPIC C-ARM ARIEL C-ARM Fischer Imaging Corp. JAA Class II 1988-02-29

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