meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
42
Latest Decision
1988-02-26

Clearances · page 135 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K874905 P2020 MOBILE C-ARM IMAGE INTENSIFIER Photo Medic Equipment, Inc. JAA Class II 1988-02-26
K874767 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-11 Shimadzu Precision Instruments, Inc. JAK Class II 1988-02-25
K874895 IR-192 IMPLANT Rads S.L., Inc. IWA Class II 1988-02-25
K875106 PB-A LEAD-ACID BATTERY CONVERSION KIT Diagnostic Imaging Specialists Corp. IZL Class II 1988-02-22
K874214 S9 DISPLAY SYSTEM O.M.I. Oncology Microsystems, Inc. JAD Class II 1988-02-22
K872525 A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH M.C. Johnson Co., Inc. KPR Class II 1988-02-22
K872369 LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM Loma Linda University Medical Center IWM Class II 1988-02-22
K874922 ACUSON TRANSPERINEAL NEEDLE GUIDE Acuson Computed Sonography ITX Class II 1988-02-19
K874893 MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR Keithley Instruments, Inc. IYE Class II 1988-02-17
K874860 ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA. Acuson Computed Sonography ITX Class II 1988-02-17
K875374 SHIMADZU CEILING-SUSPENDED C-ARM CH-50 Shimadzu Precision Instruments, Inc. IZI Class II 1988-02-12
K872920 AMICI KRYPTON ADMINISTRATION SYSTEM* Amici, Inc. IYT Class II 1988-02-12
K875375 SHIMADZU LATERAL C-ARM MH-30 Shimadzu Precision Instruments, Inc. IZI Class II 1988-02-12
K875377 SHIMADZU MAMMOGRAPHIC STAND MR-30 Shimadzu Precision Instruments, Inc. IZH Class II 1988-02-12
K875372 SHIMADZU CATHETERIZATION C-ARM STAND ER-200 Shimadzu Precision Instruments, Inc. IZI Class II 1988-02-12
K875380 SHIMADZU CATHETERIZATION C-ARM STAND MH-10 Shimadzu Precision Instruments, Inc. IZI Class II 1988-02-12
K874908 C900 X-RAY FILM PROCESSOR Summit Industries, Inc. IXW Class II 1988-02-12
K875376 SHIMADZU CATHETERIZATION C-ARM STAND MH-50B Shimadzu Precision Instruments, Inc. IZI Class II 1988-02-12
K875373 C-ARM STAND FOR BIPLANCE CINE FLUOROGRAPHY MH-20 Shimadzu Precision Instruments, Inc. IZI Class II 1988-02-12
K875379 SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A Shimadzu Precision Instruments, Inc. IZI Class II 1988-02-12
K874451 OMNIPLANE 200 FILM CHANGER SYSTEM Medrad, Inc. IZP Class II 1988-02-11
K872817 5 MHZ DOPPLER OUTRIGGER Philips Ultrasound, Inc. IYN Class II 1988-02-08
K875341 EDEC 60 R/F Electromed Intl., Ltd. IZO Class I 1988-02-01
K874901 REVELATION, RADIO FLUOROSCOPIC X-RAY EXAM TABLE Fischer Imaging Corp. JAA Class II 1988-01-29
K875184 UNICATH LAB Xre Corp. IZI Class II 1988-01-29
K875342 EDEC 90C Electromed Intl., Ltd. IZO Class I 1988-01-29
K873775 TRIAD NUCLEAR IMAGING SYSTEM Trionix Research Laboratory, Inc. KPS Class II 1988-01-19
K875157 SHIMADZU CATHETERIZATION C-ARM STAND MH-50A Shimadzu Precision Instruments, Inc. JAA Class II 1988-01-19
K873985 FLUORO COVER Condor Medical JAA Class II 1988-01-19
K875233 VARIVIEWER (X-RAY FILM VIEWER) Diversified Diagnostic Products, Inc. IXC Class I 1988-01-19
K875083 KODAK KODAFLEX II CASSETTE Eastman Kodak Company IXA Class II 1988-01-19
K874934 UNIVERSAL EXAMINATION TABLE Imatron, Inc. KXJ Class II 1988-01-19
K872288 SONOLAYER-V, SAL-38B Toshiba Medical Systems IYO Class II 1988-01-11
K874840 BENNETT PORTABLE RADIOGRAPHIC SYSTEM NO. SPR-100A Bennett X-Ray Corp. IZL Class II 1988-01-11
K874926 KODAK REMOTE ALARM UNIT Eastman Kodak Company IXW Class II 1988-01-04
K874081 ENTERSCAN Pie Data Medical BV LWI Class II 1987-12-31
K870899 EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX Biosound, Inc. ITX Class II 1987-12-30
K874687 COLLI-MATETM MODEL NO. B800 Summit Industries, Inc. IZX Class II 1987-12-30
K874865 DAMON D.E.T.E.C.T IMAGE ENHANCER Damon Corp. LLZ Class II 1987-12-23
K874787 MODIFIED PALLADIUM SEED MODEL 100 Theragenics Corp. IWI Class II 1987-12-22
K871004 EUB-410 DIAGNOSTIC ULTRASOUND DEVICE Hitachi Medical Corp. of America IYO Class II 1987-12-11
K872726 DGH-3000A A-SCAN Dgh Technology, Inc. IYO Class II 1987-12-04
K874639 REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100 Shimadzu Precision Instruments, Inc. KXJ Class II 1987-12-04
K873096 COLOR FLOW IMAGING Advanced Technology Laboratories, Inc. IYO Class II 1987-11-23
K871938 VISION CARE/PHAKOSYSTEMS ECHORULE Phakosystems, Inc. IYO Class II 1987-11-23
K874040 MAMEX DC S SL10/MG14 Orion Corp. IZH Class II 1987-11-23
K874113 OMNI DIAGNOST Xre Corp. IXR Class II 1987-11-16
K873618 STEREOTIX Thomson-Cgr Medical Corp. IZH Class II 1987-11-16
K874114 TRAUMA TABLE II Xre Corp. IXR Class II 1987-11-16
K864299 NOVO BMC-LAB 23, BONE DENSITOMETER Scan Detectronic Laboratories, Inc. KGI Class II 1987-11-12
K874118 MODEL 410 DENTAL X-RAY FILM PROCESSORS Dent-X Co. EGY Class II 1987-11-06
K873314 TOSHIBA, SMIT ROENTGEN Inland Tube Corp. ITY Class I 1987-11-02
K873580 MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR Medical High Technology International, Inc. KPQ Class II 1987-11-02
K871810 PLAN-32 SOFTWARE Oncology Systems, Inc. JAD Class II 1987-10-30
K873956 ULTIMETER Radiation Measurements, Inc. LHO Class I 1987-10-30
K873982 GX-MOBILE X-RAY UNIT Gendex Corp. IZL Class II 1987-10-30
K873075 ADAC MODEL ARC-5000, GAMMA CAMERA Adac Laboratories JWM Class II 1987-10-30
K873048 KODAK SV6500 PRINTER/ SV65 FINISHER/ SV100 SET Eastman Kodak Company LMB Class I 1987-10-30
K873849 ALTAIREX BUCKY/CASSETTE TRAY COMBINATION Altairex Manufacturing, Inc. IXQ Class II 1987-10-28
K873544 MPG-50 X-RAY GENERATOR Thomson-Cgr Medical Corp. IZO Class I 1987-10-26
K872132 SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS Sopha Medical Systems, Inc. IXY Class I 1987-10-26
K871446 HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1 Hologic, Inc. KGI Class II 1987-10-20
K865107 AERO-VENT AEROSOL UNIT Medi Nuclear Corp., Inc. IYT Class II 1987-10-20
K873836 MAMMOGRAPHIC KVP METER MODEL 232 Radiation Measurements, Inc. IZH Class II 1987-10-16
K873646 DIGIVIEWER Digivision, Inc. LLZ Class II 1987-10-08
K872734 MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE Palomex Instrumentarium Corp. IZH Class II 1987-10-08
K871553 X-CALIBER MODEL 1000 BONE MINERAL ANALYZER Hologic, Inc. KGI Class II 1987-10-08
K870967 ADMS TRANSRECTAL 7.5 MHZ PROBE Diasonics, Inc. ITX Class II 1987-09-29
K872615 IMATRON C-100 ULTRAFAST CT SCANNER Imatron, Inc. JAK Class II 1987-09-23
K872526 CT PACE CATALOG NUMBER B7950A General Electric Co. JAK Class II 1987-09-23
K873283 MODEL C2-5000 OVERHEAD TUBE SUPPORT Transworld X-Ray Corp. IYB Class I 1987-09-10
K872307 VOLUMETRIC PACKAGE STEPPER H4222AA/CALCU. H4222AB General Electric Co. IYO Class II 1987-09-08
K872455 DPS-4100 PLUS DIGITAL RADIOGRAPHY SYSTEM Adac Laboratories LLZ Class II 1987-09-01
K871048 MICRO MAMMO I MAMMOGRAPHY UNIT Amerasia Import-Export, Inc. IZH Class II 1987-09-01
K873167 KODAK MIN-R MEDIUM SCREEN Eastman Kodak Company EAM Class I 1987-08-27
K872980 MAM-CP X-RAY APPARATUS Transworld X-Ray Corp. IZH Class II 1987-08-27
K871536 OPHTHASONIC A-SCAN/ B-SCAN Teknar, Inc. IYO Class II 1987-08-26
K854654 SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007 Philips Medical Systems, Inc. IYO Class II 1987-08-19
K872027 OLYMPUS GF-UM2/EU-M2 Olympus Corp. IYO Class II 1987-08-17
K872292 TRANSPECT TRANSCRANIAL DOPPLER Medasonics, Inc. IYN Class II 1987-08-14
K872894 A2J MZ 44 LASER LIGHT FOR POSITIONING Prometex, Inc. IWE Class I 1987-08-12
K872150 I.S.G. 3DMV WORKSTATION I.S.G. Technologies, Inc. JAK Class II 1987-08-12
K872316 BC 1400 HAND POSITIONER Instrumentation Industries, Inc. KPR Class II 1987-08-12
K871984 KODAK EKTASCAN IMAGE TRANS. T1/R1 & P1 SOFTWARE Eastman Kodak Company LMD Class I 1987-08-12
K872445 POWER-AID INDEPENDENT X-RAY POWER SOURCE Advanced Instrument Development, Inc. IZO Class I 1987-08-12
K872841 ACCULITE Medical Alignment Systems IWE Class I 1987-08-12
K872317 BC 1800 FINGER POSITIONER Instrumentation Industries, Inc. KPR Class II 1987-08-12
K872297 DS-7 NUCLEAR MEDICINE GAMMA CAMERA Sopha Medical Systems, Inc. IYX Class I 1987-08-12
K871859 CT9800 QUICK 3D #B7919DA General Electric Co. JAK Class II 1987-08-12
K864624 PROBE, UPTAKE, NUCLEAR Carolina Medical Electronics IZO Class I 1987-08-10
K871432 3.0 MHZ PHASED ARRAY SCANHEAD W/2.0 MHZ SIDEARM CW Advanced Technology Laboratories, Inc. ITX Class II 1987-08-07
K863269 SONOLAYER - V, SSA-100A. Toshiba Medical Systems ITX Class II 1987-07-22
K871216 HILARIS-NORI ENDOMETRIAL APPLICATOR Mick Radio-Nuclear Instruments, Inc. IWJ Class I 1987-07-21
K872656 LEAD GLASS SHIELDS Viox Corp. IWR Class I 1987-07-16
K871217 HENSCHKE AFTERLOADING APPLICATOR Mick Radio-Nuclear Instruments, Inc. IWJ Class I 1987-07-16
K871213 KUMAR CERVICAL APPLICATOR Mick Radio-Nuclear Instruments, Inc. IWJ Class I 1987-07-16
K872357 TRANSWORLD 360V, MODEL A1-4040 Transworld X-Ray Corp. IZO Class I 1987-07-15
K872489 CENTRALITE Diacor, Inc. IWE Class I 1987-07-15
K871609 ULTRASOUND TRANSDUCER SHEATHS, STERILE Amedic USA ITX Class II 1987-07-15
K862511 TOMOMATIC 232 Medimatic KPS Class II 1987-07-10

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