meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
42
Latest Decision
1983-12-29

Clearances · page 142 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K834306 PHASIX-HIGH FREQUENCY GENERATOR Cgr Medical Corp. ITY Class I 1983-12-29
K834288 DIGITILT LS-30 REMOTE CONTROL Elscint, Inc. IZF Class II 1983-12-29
K833941 ORION Cgr Medical Corp. IYE Class II 1983-12-29
K834027 GOLD SEADS Radiation Safety & Nuclear Products, Inc. IWG Class II 1983-12-27
K833811 CARDIAC CAMERA Siemens Gammasonics, Inc. IYX Class I 1983-12-27
K833846 PROCESS 100 ST Cgr Medical Corp. IZO Class I 1983-12-16
K833847 CRISA X-Ray Tube Corp. ITY Class I 1983-12-12
K833237 DIGITAL RADIOGRAPHY SYS DUAL GANTRIES American Science and Engineering, Inc. JAA Class II 1983-12-08
K833140 THYROID UPTAKE SYSTEM Advanced Medical Research Corp. IZD Class I 1983-12-08
K833531 CT SCANNING ACCESSORIES Lds Hospital JAA Class II 1983-12-08
K832895 VISION TWO, ONE/10 ONE/20 &24 Comtal Corp. LLZ Class II 1983-12-08
K833560 RTP-5100-5200-5300 & 5400 Adac Laboratories JAD Class II 1983-12-08
K833224 BIFOCAL 3.0MHZ Adr Ultrasound ITX Class II 1983-11-29
K833222 SINUSVU 2500 Radionics Medical, Inc. IYO Class II 1983-11-28
K833525 CEMAX-1000 Contour Medical Systems, Inc. LMB Class I 1983-11-21
K833530 DIGITAL FLUOROGRAPHIC X-RAY SYSTEM General Electric Co. JAA Class II 1983-11-21
K833239 PORTA. X-RAY UNIT FP220 SCM-1-ETC, Showa X-Ray Co., Ltd. IZL Class II 1983-11-21
K833230 REGISTREX 1000 DIGITAL RADIOGRAPHY SYS Advanced Technology Laboratories, Inc. JAA Class II 1983-11-21
K833523 C.B. RADIOLOGY DESIGN GONADSHIELD Radiology Design IWT Class I 1983-11-21
K833243 MAMMOGRAPHIC S-RAY SYSTEM Xerox Medical Systems IZH Class II 1983-10-28
K833233 HOT SHOT Schiff Photo Mechanics IYO Class II 1983-10-28
K833234 KODAK T-MAT L FILM SO-387 Eastman Kodak Company IWZ Class I 1983-10-28
K833238 CRISA X-Ray Tube Corp. ITY Class I 1983-10-28
K833228 INSTANT IMAGER Schiff Photo Mechanics JAK Class II 1983-10-28
K833226 PMX MOBILE X-RAY SYSTEM Philips Medical Systems, Inc. IZL Class II 1983-10-28
K832733 XEROX 120 SYS MAMMOGRAPHIC X-RAY Xerox Medical Systems IZH Class II 1983-09-29
K832732 RADIOTHERAPY MGMT. SYSTEM RMS-1000 Varian Assoc., Inc. IYE Class II 1983-09-29
K832603 CURIX CAPACITY FILM CENTER Agfa-Gevaert, Inc. IXW Class II 1983-09-29
K832789 AFTER LOADING BUCHLER Ellis Pharmaceutical Consulting, Inc. JAQ Class II 1983-09-29
K832738 HEYER-SCHULTE AFTERLOADING CATHETER American Heyer Schulte IWJ Class I 1983-09-29
K832602 THYROID PROTECTIVE COLLAR E.M. Adams EAJ Class I 1983-09-29
K832737 ECT PROCESSOR Siemens Gammasonics, Inc. JWM Class II 1983-09-29
K832601 LEADED X-RAY APRON E.M. Adams EAJ Class I 1983-09-29
K832504 CRONEX LO-DOSE MAMMOGRAPHY E.I. Dupont DE Nemours & Co., Inc. IWZ Class I 1983-09-12
K832502 ELECTRON BEAM OPTION FOR CLINAC 15 MEV Varian Assoc., Inc. IYE Class II 1983-09-12
K832503 CLINAC 1800 Varian Assoc., Inc. IYE Class II 1983-09-12
K832505 IMAGE PROCESSING SYS A3 Metronic, Inc. IYX Class I 1983-09-12
K832216 VARIAN CLINACOMP 100 TISSUE COMPENSATOR Varian Assoc., Inc. IYE Class II 1983-09-12
K837776 AOR X-RAY ALIGMENT PAD Zimmer, Inc. IXJ Class I 1983-08-18
K832331 US-1000 ULTRASONIC IMAGING SYSTEM Nidek, Inc. IYO Class II 1983-08-16
K837347 LINEAR ACCELERATOR THERAC 25 Atomic Energy of Canada IYE Class II 1983-06-24
K837152 THERAC 25 LINEAR ACCELERATOR Atomic Energy of Canada JAI Class II 1983-03-22
K827489 HYPERLUX 30 IMAGE SYSTEM Cgr Medical Corp. JAA Class II 1982-11-04
K827928 VRT TABLE General Electric Co. IZZ Class II 1982-09-29
K827583 STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE Nucletronix, Inc. IWB Class II 1982-09-29
K822602 HEMACOUNT WRIGHT GIEMSA STAIN PACK Accra Laboratories, Inc. JAF Class II 1982-09-17
K820042 OCULAR-BIOMETER 4000 Radionics, Inc. IYO Class II 1982-07-22
K820658 LIXISCOPE - OR LIXI Lixi, Inc. OXO Class II 1982-05-18
K827296 POLYSONIC ULTRASOUND LOTION Parker Laboratories, Inc. MUI Class II 1982-04-16
K813275 EPCOM EMS SCAN II Epcom Medical Systems, Inc. IYO Class II 1982-03-31
K820310 DELTA PLAN II RADIATION THERAPY PLAN Technicare Corp. IYE Class II 1982-03-31
K820571 XENAMATIC SERIES OF XENON REBREATH DEV Diversified P.A. IYT Class II 1982-03-31
K820448 ARS-1000 Applied Radiation IYE Class II 1982-03-31
K820688 ARRANGE TM General Electric Co. JAK Class II 1982-03-31
K820364 MARK 500 ULTRASOUOND SYSTEM Advanced Technology Laboratories, Inc. IYO Class II 1982-03-26
K820365 MARK 100 & 300 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. IYO Class II 1982-03-26
K813596 AUTO SECTOR MCU Technicare Corp. IYO Class II 1982-03-25
K820593 ESP SERIES (X-RAY GENERATORS Xonics Medical Systems, Inc. IZO Class I 1982-03-19
K812686 SINUSCOPE Jedmed Instrument Co. IYO Class II 1982-03-05
K820306 RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC Tecnomed, Inc. KPW Class II 1982-03-05
K820124 INTEGRAL SECTOR MODULE Siemens Gammasonics, Inc. IYO Class II 1982-03-05
K813177 US ALOKA SSD-256 ULTRASONIC SCANNER U. S. A. Imaging Corp. IYO Class II 1982-03-05
K820307 TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE Tecnomed, Inc. IZO Class I 1982-03-05
K820305 RALCO COLLIMATORS, MANUAL RADIOGRAPHIC Tecnomed, Inc. KPW Class II 1982-03-04
K820178 PI808 MOBILE C-ARM IMAGE INTENSIFIER Precise Optics JAA Class II 1982-03-04
K820143 XENON DELIVERY SYSTEM Vital Signs, Inc. IYT Class II 1982-03-02
K820244 ADD'L TERMINAL SUPPORT FOR STAR BASIC General Electric Co. IYX Class I 1982-03-02
K813397 SSD-240 ULTRASONIC SCANNER U. S. A. Imaging Corp. IYO Class II 1982-03-02
K813398 SSD-203 ULTRASONIC SCANNER U. S. A. Imaging Corp. IYO Class II 1982-03-01
K820112 SIEMENS POLYDOROS 800 Siemens Corp. IZO Class I 1982-02-24
K820184 LATERAL ANGULATING FLUORO SUSPENSION General Electric Co. JAA Class II 1982-02-24
K813543 ADR ULTRASOUND MODELS 4000S & 4000S/L Adr Ultrasound IYO Class II 1982-02-24
K820117 AUTOMATIC TRAY (ACT I & ACT II Burbury & Cutter Ind., Inc. KPX Class II 1982-02-18
K820119 PODIOSCOPE BY ARROW Arrow X-Ray Corp. KPW Class II 1982-02-18
K820111 SIEMENS SIRESKOP 4 Siemens Corp. KXJ Class II 1982-02-18
K813544 IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS. Irex Corp. IYN Class II 1982-02-05
K813588 CTF MODEL 9300 Thomson-Csf Broadcast, Inc. IZI Class II 1982-02-04
K813561 SPECTRUM PEDIATRIC CARDLE TABLE Spectrum X-Ray Corp. KXH Class I 1982-01-29
K812435 DATAPASS General Electric Co. IYO Class II 1982-01-28
K812776 TRANSDUCER ANTISEPTIC TOWELETTE Echo Laboratories, Inc. ITX Class II 1982-01-25
K813379 RADIONUCLIDE DOSE CALIBRATOR Medi Nuclear Corp., Inc. KPT Class II 1982-01-22
K813439 RTP-5000 Adac Laboratories JAD Class II 1982-01-22
K813158 RDP-2000 Machlett Laboratories, Inc. JAA Class II 1982-01-19
K813196 IMAGE ANALYSIS CENTER Technicare Corp. JAK Class II 1981-12-29
K813217 DIGITAL FLUROGRAPHIC IMAGING SYSTEM Diasonics, Inc. JAA Class II 1981-12-29
K813230 AFTERLOADING GYNECOLOGICAL APPLICATOR Esi IWJ Class I 1981-12-29
K813147 KODAK INTENSIFYING SCREEN 80-175 Eastman Kodak Company EAM Class I 1981-12-14
K813162 INTERAD WHOLE BODY CT SCANNER Interad Systems, Inc. JAK Class II 1981-12-14
K813173 VRT TABLE W/INTEGRATING TUBE STAND/ELEV General Electric Co. KPR Class II 1981-12-14
K812893 SUPERFLAB Mick Radio-Nuclear Instruments, Inc. IYP Class I 1981-12-08
K813065 B.D.A.S. General Electric Co. KPT Class II 1981-12-08
K812613 VIDICAM 200 Diversified P.A. IZJ Class II 1981-12-08
K813139 KODAK INTENSIFYING SCREEN SO-168 Eastman Kodak Company EAM Class I 1981-12-08
K813073 OMEGA 500 RECTANGULAR FIELD CAMERA W/SC Technicare Corp. IYX Class I 1981-12-08
K813128 MOBIL-AID AUTOMATIC EXPOSURE CONTROL Advanced Instrument Development, Inc. IZL Class II 1981-12-03
K813051 COMPTAR III Cgr Medical Corp. IZO Class I 1981-11-24
K812929 3.5 MHZ BIOPSY TRANSDUCER General Electric Co. ITX Class II 1981-11-24
K812963 IBIS II Cgr Medical Corp. JAA Class II 1981-11-24
K812966 400T ECT SOFTWARE General Electric Co. JWM Class II 1981-11-24
K812913 OMEGA II ANGIOGRAPHIC TABLE General Electric Co. IZI Class II 1981-11-24

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