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Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
40
Latest Decision
1984-08-23

Clearances · page 141 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K840140 DOPPLER IMAGING OPTION Hewlett-Packard Co. IYN Class II 1984-08-23
K842911 PUCK U & UD CUTFILM CHANGERS Elema-Schonander, Inc. KPX Class II 1984-08-21
K841964 MICRO DELTA & CELTAPRO Computer Design & Applications, Inc. IYX Class I 1984-08-21
K842903 SEP PROGRAMMER FOR PUCK U & UD FILMCHANG Elema-Schonander, Inc. IZP Class II 1984-08-21
K842494 MATRIS INSTRU. VIDEO IMAGER 1010- Matrix Instruments IZI Class II 1984-08-17
K842495 MATRIX VIDEO IMAGER 1020 COMPACT CAMER Matrix Instruments IZI Class II 1984-08-17
K841817 TECHNICARE 248 SL & 260SL Technicare Corp. IYO Class II 1984-08-17
K842348 SPX GENERATOR General Electric Co. IZO Class I 1984-08-17
K841923 DCX-100 CHEST UNIT-GL-5000M Transworld X-Ray Corp. KPR Class II 1984-08-10
K841905 DOT-A, DOT-AR PXP-E, PXP-ER Siemens Gammasonics, Inc. JWM Class II 1984-08-09
K842540 CLINICOMP R.C.I. Clinicomp, Inc. KPT Class II 1984-08-08
K842614 CAROLINA X-RAY CO. SIMPLAFLOAT TABLE Carolina X-Ray Co., Inc. IXQ Class II 1984-08-08
K842570 LUDLUM 88 DOSE CALIBRATOR Ludlum Measurements, Inc. KPT Class II 1984-08-07
K842591 ULTRASOUND PROBE COVERS-STERILE Applied Medical Devices, Inc. IYO Class II 1984-07-23
K841359 FENESTRA HOOK Treace Medical, Inc. IYL Class II 1984-07-18
K842153 ULTRASOUND TRANSMISSION GEL Wpc Brands, Inc. IYO Class II 1984-07-18
K841463 BONE DENSITOMETER Norland Corp. KGI Class II 1984-07-17
K842184 SPOT-FILM DEVICE 8835 General Electric Co. IXL Class II 1984-07-17
K842102 LORAD Lorad Medical Systems, Inc. IZH Class II 1984-07-17
K841787 RADCAL MODEL 4050 RADIONUCLIDE CALIB Radcal Corp. KPT Class II 1984-07-16
K841786 RADCAL MODEL 4051 RADIONUCLIDE CALIBRA Radcal Corp. KPT Class II 1984-07-16
K841996 MAXICAMERA 400T W/BODY CONTOUR TOMOGRA General Electric Co. JAM Class I 1984-07-16
K841785 RADCAL MODEL 4046 RADIONUCLIDE CALIBR Radcal Corp. KPT Class II 1984-07-16
K841431 RADIOGRAPHIC FILM PROCESSOR M-30CR & The Allen Products Co. IXX Class II 1984-07-06
K841756 LIEBEL-FLARSHEIM ACS 1000 CHEST X-RAY Syvron Corp. KPR Class II 1984-07-06
K841906 MAXICAMERA 400 AC General Electric Co. IYX Class I 1984-07-06
K841774 UNIMACS, PATENT PENDING UNIVERSAL MAM Technical Devices For Medicine IZH Class II 1984-06-26
K840953 ACCESS SCANHEADSS Advanced Technology Laboratories, Inc. IYN Class II 1984-06-15
K841440 ND62T THYROID UPTAKE SYSTEM Nuclear Data, Inc. IZD Class I 1984-06-05
K841649 MAXIMAX - 4 Cgr Medical Corp. IZP Class II 1984-06-05
K840621 FLUOROSCOPIC IMAGE INTENSIFIER Phoenix Radiology, Ltd. JAA Class II 1984-06-05
K833779 YTTRO FILTER Yttro Corp. IZW Class II 1984-06-05
K841732 LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM Sybron Corp. IZP Class II 1984-06-05
K840860 CENTAURI CT SCANNER Technicare Corp. JAK Class II 1984-05-22
K840451 BIOPSY ATTACHMENT;DYNEX ULTRASOUND- Elscint, Inc. IYO Class II 1984-05-09
K840139 IREX 720 SECTOR SCANNER Irex Corp. IYO Class II 1984-05-09
K834284 ULTRASOUND SCANNER 501 Imex Medical Systems, Inc. IYO Class II 1984-05-09
K840540 TECHNICARE MODEL 330 Technicare Corp. IYO Class II 1984-05-09
K840402 AUDIO BANDWIDTH ANALYZER D. E. Hokanson, Inc. IYN Class II 1984-05-09
K833223 SONEL 3000A Cgr Medical Corp. IYO Class II 1984-05-09
K841332 CIVCO/SUPER SCAN CIVCO Medical Instruments Co., Inc. IYO Class II 1984-05-09
K833667 DIASONICS DLA-100 Diasonics, Inc. IYO Class II 1984-05-09
K834280 SDL-30 Shimadzu Corp. IYO Class II 1984-04-25
K840138 QTA PROCESSOR MODULE General Electric Co. IYO Class II 1984-04-25
K840408 LINEAR ARRAY TRANSDUCER OR SCANHEAD Adr Ultrasound IYO Class II 1984-04-25
K840806 FR MEDICAL X-RAY FILM Fr Medical/Fr Chemicals IWZ Class I 1984-04-24
K834282 ULTRA IMAGER 2000 Honeywell, Inc. IYO Class II 1984-04-23
K840667 LINEAR SCANNER 640 Ge Medical Systems Information Technologies IYO Class II 1984-04-23
K840611 DSL-150 Shimadzu Corp. IYO Class II 1984-04-20
K834141 ULTRASOUND SCAN HEAD 3.5 MHZ Adr Ultrasound IYO Class II 1984-04-20
K834486 TECHNICARE 280 Technicare Corp. IYO Class II 1984-04-13
K840135 CRISA X-Ray Tube Corp. ITY Class I 1984-03-23
K840156 PROTECTA COAT SPONGES Alimed, Inc. IZZ Class II 1984-03-23
K840227 UROLIX-3 UROLOGICAL TABLE Medicor USA , Ltd. IXR Class II 1984-03-23
K840225 C-ARM CEILING CRANE FT-2 Medicor USA , Ltd. JAA Class II 1984-03-22
K840052 DIGITAL PROCESSING SYSTEM Adac Laboratories IYX Class I 1984-03-22
K840364 REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY Advanced Technology Laboratories, Inc. JAA Class II 1984-03-19
K840127 CURIETRON Syncor Intl. Corp. JAQ Class II 1984-03-19
K840678 UXM MODEL 8188 Universal X-Ray IZX Class II 1984-03-16
K840134 CAMTEX 1000 Digital Imaging Co. of America JAA Class II 1984-03-16
K840136 LINEAR ACCELERATOR MULTIPLE EXL 3-4-6 Adac Laboratories IYE Class II 1984-03-16
K840191 DIGITAL FLUOROGRAPHY X-RAY SYSTEM Adac Laboratories JAA Class II 1984-03-16
K840698 POWERMAT VRP-1 X-RAY IMAGING Powers Chemco, Inc. IWZ Class I 1984-03-16
K840226 MOTOR TILTED EXAM. TABLE UV-56 Medicor USA , Ltd. IXR Class II 1984-03-16
K834614 WILCOR-XR RP-L MEDICAL FILM Cea America Corp. IWZ Class I 1984-03-05
K834613 WILCOR-XR RP MEDICAL FILM Cea America Corp. IWZ Class I 1984-03-05
K834483 DIGI-X Radiation Measurements, Inc. LHO Class I 1984-03-05
K840607 LF MOTORIZED RADIOGRAPHIC FILM VIEWER Sybron Corp. IXC Class I 1984-03-05
K834201 TCT-1 TREATMENT COUCH Therados, Inc. JAI Class II 1984-03-05
K833225 CALIBRE-TENTATIVE TRADENAME Advanced Technology Laboratories, Inc. IYO Class II 1984-02-28
K834612 WILCOR-XR RP-OG MEDICAL FILM Cea America Corp. IWZ Class I 1984-02-27
K834087 MODEL XLE Interad Systems, Inc. IYO Class II 1984-02-27
K840385 VIDEO PRINT Advanced Instruments, Inc. LMC Class II 1984-02-27
K834496 ISOREX LS-36 Elscint, Inc. IZI Class II 1984-02-21
K834465 SERIES OF DIAGNOSTIC PHANTOMS Cirs, Inc. IXG Class I 1984-02-21
K834607 ELECTRONIC KVP CASSETTE Radiation Measurements, Inc. IWN Class I 1984-02-21
K834478 CHICK/REISON PATIENT EMERG. TROLLEY Professional Medical Products, Inc. KXJ Class II 1984-02-21
K840463 DIGITAL CRADLE Spectrum X-Ray Corp. KXH Class I 1984-02-21
K834494 SPECTRUM X-RAY CORP Spectrum X-Ray Corp. IZZ Class II 1984-02-21
K834484 CRONEX SR-337 E.I. Dupont DE Nemours & Co., Inc. EAM Class I 1984-02-21
K834307 ULTRASOUND SCANNER XL Interad Systems, Inc. IYO Class II 1984-02-21
K834611 SINGUL-XR RP NON SCREEN MED. FILM Cea America Corp. IWZ Class I 1984-02-21
K834559 DELUXE WALL-MOUNTED CEPHALOMETER Knochen Dental Laboratory IWY Class I 1984-02-21
K840390 TECHNICARE MODEL 1047 Technicare Corp. JAA Class II 1984-02-21
K840131 COMPUTED TOMOGRAPHY CALIBRATION PHANT Imatron, Inc. IXG Class I 1984-02-21
K840389 SEP PROGRAMMER SEP-M/SINGLE-PLANE & Elema-Schonander, Inc. IZP Class II 1984-02-21
K834276 MOD 456 Hoffrel Instruments, Inc. IYO Class II 1984-02-17
K834277 MOD 427 Hoffrel Instruments, Inc. IYO Class II 1984-02-17
K833680 SIGMA 20 ELECTRONIC SECTOR SCANNER Kontron Instruments, Inc. IYO Class II 1984-02-17
K834285 KC 100 M Elscint, Inc. IYO Class II 1984-02-17
K833231 SOUND IMAGER I Sound Imaging, Inc. IYO Class II 1984-02-04
K834482 TISSUE MIMICKING ULTRASOUND PHANTOMS Radiation Measurements, Inc. IXF Class I 1984-01-25
K834481 DOPPLER PHANTOM FLOW CONTROL SYS Radiation Measurements, Inc. IXF Class I 1984-01-25
K833821 INTERAD 520 Interad Systems, Inc. IYX Class I 1984-01-13
K834287 DIGITAL RADIOGRAPHY SYS-DPS7100 Adac Laboratories JAA Class II 1984-01-10
K834308 MULTITREAT 48 Mick Radio-Nuclear Instruments, Inc. JAQ Class II 1984-01-10
K834286 BI-PLANE DIGITAL FLUOROGRAPHY DFX7000 Adac Laboratories JAA Class II 1984-01-04
K833559 ARMBOARD Mtd, Inc. KPR Class II 1984-01-03
K833641 IMAGE INTENSIFIER TUBE W/HOUSING & Varian Assoc., Inc. JAA Class II 1983-12-30
K834281 RAD II SIMULATOR Haynes Radiation Ltd., Inc. KPQ Class II 1983-12-29

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