meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
36
Latest Decision
1986-11-10

Clearances · page 137 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K863041 3.5 MHZ SECTOR PROBE, MODEL 8818098 LH306 Siemens Medical Solutions USA, Inc. IYO Class II 1986-11-10
K863043 3.5 MHZ SECTOR PROBE, MODEL 8818080 LH 305 Siemens Medical Solutions USA, Inc. IYO Class II 1986-11-10
K864046 C-IOO MOBILE CINE CT UNIT Imatron, Inc. JAK Class II 1986-11-10
K863096 5.O MHZ SECTOR PROBE, MODEL 8818106 LH 307 Siemens Medical Solutions USA, Inc. IYO Class II 1986-11-10
K862164 EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER Hitachi Medical Corp. of America IYO Class II 1986-11-04
K863996 MODEL XE-103 XENON/MASTER II Medi Nuclear Corp., Inc. IYT Class II 1986-11-04
K862911 BI-PLANE TRANSRECTAL PROBE NUMBER H4221T General Electric Co. ITX Class II 1986-10-31
K862339 MEVATRON KD-2 Siemens Medical Laboratories, Inc. IYE Class II 1986-10-29
K863778 VENTICIS II Cis-Us, Inc. IYT Class II 1986-10-27
K863629 KODAK EKTASCAN LASER PRINTER, MODEL 100 Eastman Kodak Company LMC Class II 1986-10-27
K863180 THERATRON-PHOENIX Aecl Medical IWB Class II 1986-10-27
K863286 ERS SYSTEM General Electric Co. LMB Class I 1986-10-27
K864042 MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH Absolute X-Ray Corp. ITY Class I 1986-10-27
K862842 ADVANCED NUCLEAR COMPUTER Advanced Nuclear Imaging Corp. LMB Class I 1986-10-27
K852502 AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849 Bruel & Kjaer Industri A/S IYO Class II 1986-10-23
K862715 COMMVIEW SYSTEM A T & T Technologies, Inc. LMD Class I 1986-10-16
K863890 MAMM-AIRE Ar Custom Medical Products, Ltd. KXH Class I 1986-10-14
K863710 ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT Ausonics Pty , Ltd. IZH Class II 1986-10-14
K863856 S-RAY CAMERA Uni-Quatro Industries LMC Class II 1986-10-14
K861852 CSI/MPR OR CSI/MPR PLUS Columbia Scientific, Inc. LLZ Class II 1986-10-08
K862317 CT MAX, CATALOG NO. B7940 HA General Electric Co. JAK Class II 1986-10-07
K861698 VISISCAN CT SCANNERS - MODELS V600, V1200 & V2400 Visiscan JAK Class II 1986-10-03
K862645 CLINAC (R) C SERIES (400C, 600C, 2100C, 2500C) Varian Assoc., Inc. IYE Class II 1986-10-03
K862151 COLOR FLOW MAPPING (CFM) OPTION - MODEL 77020 CF Hewlett-Packard Co. IYO Class II 1986-09-19
K863358 VARIAN RMS-2000 Varian Assoc., Inc. IYE Class II 1986-09-19
K862825 HI-LO ELEVATOR FLAT TABLE Garrels X-Ray Products, Inc. IXQ Class II 1986-09-04
K854653 CILCO SONOMETRICS DIGICON CooperVision, Inc. IYO Class II 1986-09-04
K862616 AMBER-CHEST Old Delft Corp. of America KPR Class II 1986-09-02
K861708 SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC General Electric Co. JAK Class II 1986-08-29
K862065 PC-PLAN Dosimetrix, Inc. IYE Class II 1986-08-26
K861538 860 COLOR DOPPLER OR COLORVIEW 860 Ge Medical Systems Information Technologies IYO Class II 1986-08-25
K860009 5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM Johnson & Johnson Professionals, Inc. ITX Class II 1986-08-20
K862166 SONORANGER Ausonics Pty , Ltd. IYO Class II 1986-08-18
K862800 SMX GENERATOR General Electric Co. IZO Class I 1986-08-14
K862944 KODAK CFT FILM SO-141 Eastman Kodak Company IWZ Class I 1986-08-12
K860568 ULTRASONIC IMAGING SYSTEM (MODIFIED) Interspec, Inc. ITX Class II 1986-08-11
K852331 SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC Scholten Surgical Instruments, Inc. IZI Class II 1986-08-01
K862828 BSX BUCKY-STAND Garrels X-Ray Products, Inc. IXY Class I 1986-08-01
K862795 MP-070-M RADIOAEROSOL KIT Medipart Jerry Alexander IYT Class II 1986-08-01
K862734 CEILSTAND, MULTISTAND R & S AND THE BUCKYSTAND D&R X-Ray Products, Inc. IYB Class I 1986-08-01
K862826 ITT INTERGRATED TABLE AND TUBESTAND Garrels X-Ray Products, Inc. IXQ Class II 1986-08-01
K862791 MP-30XM-IE FACE MASK AND FILTER KIT Medipart Jerry Alexander IYT Class II 1986-08-01
K862792 MP-066 RADIOAEROSOL KIT Medipart Jerry Alexander IYT Class II 1986-08-01
K862794 MP-070 RADIOAEROSOL KIT Medipart Jerry Alexander IYT Class II 1986-08-01
K862827 FCW TUBE STAND Garrels X-Ray Products, Inc. IYB Class I 1986-08-01
K862793 MP-066-M RADIOAEROSOL KIT Medipart Jerry Alexander IYT Class II 1986-08-01
K861358 PS SYSTEM WITH SD-200 DOPPLER Johnson & Johnson Professionals, Inc. ITX Class II 1986-07-30
K862682 MVP GENERATOR, CATALOG NO. H8018 General Electric Co. IZO Class I 1986-07-29
K861941 COLLIMATOR MODEL A280BLMD & MODEL A280BLMP D&R X-Ray Products, Inc. IZX Class II 1986-07-25
K861942 COLLIMATOR MODEL A280BLE & MODEL A280-BLM D&R X-Ray Products, Inc. IZW Class II 1986-07-25
K861429 DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE Siemens Gammasonics, Inc. LLZ Class II 1986-07-25
K860697 ULTRASOUND IMAGING SYSTEM MODEL 280 SL Johnson & Johnson Professionals, Inc. IYO Class II 1986-07-24
K862452 MX MOBILE X-RAY SYSTEM Philips Medical Systems (Cleveland), Inc. IZL Class II 1986-07-22
K861994 MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM Medicor USA , Ltd. KPR Class II 1986-07-18
K860531 SONOLAYER-L, SAL-38A, WITH SCANNER SAL-38AS Toshiba Medical Systems ITX Class II 1986-07-18
K862681 ULTRAMARK 1 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. IYO Class II 1986-07-16
K862575 UNIVERSAL STAND FOR FILM CHANGER Canon USA, Inc. KPX Class II 1986-07-14
K861237 VASOVIEW DUPLEX IMAGING SYSTEM Sonicaid, Inc. ITX Class II 1986-07-14
K862595 KODAK M35A X-OMAT PROCESSOR Eastman Kodak Company IXW Class II 1986-07-11
K862340 SENTEC LASER GUIDE LINE, MODEL SGL-05 Sentec Corp. IZW Class II 1986-07-11
K861109 CW DOPPLER STATIC TRANSDUCERS Advanced Technology Laboratories, Inc. ITX Class II 1986-07-08
K860123 5.0 MHZ INTRAOPERATIVE ARRAY Siemens Medical Solutions USA, Inc. IYO Class II 1986-07-07
K861376 COMBISON R 320A Cone Instruments, Inc. IYO Class II 1986-07-03
K861228 7.5 MHZ LINEAR PROBE (ULTRASONIC TRANSDUCER) General Electric Co. ITX Class II 1986-07-03
K860472 NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS Nuclear Diagnostics, Inc. IWE Class I 1986-07-03
K862416 FTI 100 MEDICAL THERMAL IMAGER Parexel Intl. Corp. LMC Class II 1986-07-01
K862415 TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM Parexel Intl. Corp. IWZ Class I 1986-07-01
K861335 STORZ COMPUSCAN 68K Storz Instrument Co. IYO Class II 1986-06-30
K853565 ARTIS ULTRASOUND IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc. IYO Class II 1986-06-30
K862144 X-MAT Combined Concepts, Inc. KXJ Class II 1986-06-25
K854337 SDL-300 Shimadzu Corp. ITX Class II 1986-06-20
K861995 MODEL RS-3 RADIOGRAPHIC STAND Medicor USA , Ltd. IYB Class I 1986-06-19
K860776 MATRIX LR, LR 22A & LR/LASER RECORDER Matrix Instruments LMC Class II 1986-06-16
K860081 ESI 2000 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCERS Elscint, Inc. IYO Class II 1986-06-16
K862118 MODEL MBA-130 MOBILE X-RAY SYSTEM Elscint, Inc. IZL Class II 1986-06-16
K862120 SCX SYSTEM General Electric Co. JAA Class II 1986-06-16
K861279 FLUORO PLUS Advantage Medical Systems, Inc. LLZ Class II 1986-06-16
K860553 STORZ, ALPHA II BIOMETRIC RULER Storz Instrument Co. ITX Class II 1986-06-16
K854959 LINEAR SCANNER PROBE, MODEL TL-50 Elscint, Inc. IYO Class II 1986-06-16
K861785 FLUOROSCOPE BAND BAG Medi-Plast Intl., Inc. JAA Class II 1986-06-13
K860760 ERBIUM X-RAY FILTER Reactor Experiments, Inc. ITY Class I 1986-06-10
K861637 WEIGHTED ACQUISITION MODULE Siemens Gammasonics, Inc. IYX Class I 1986-06-10
K861928 STERILE O. R. TOWEL Anago, Inc. IXX Class II 1986-06-09
K861940 RADIOGRAPHIC TABLES MODELS A71OS-T,A71OT-T,A71OB-T D&R X-Ray Products, Inc. IZZ Class II 1986-05-29
K860281 CONVEX PROBE, PVE-382M Toshiba Medical Systems ITX Class II 1986-05-27
K860361 DIASONICS 3.5 GWA 30MM PROBE Diasonics, Inc. ITX Class II 1986-05-27
K861431 THERAPAX HT 150T Old Delft Corp. of America JAD Class II 1986-05-21
K853912 MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS Nucletron-Oldelft Corp. JAQ Class II 1986-05-21
K860235 MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER Hoffrel Instruments, Inc. ITX Class II 1986-05-15
K860025 MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR Medicor USA , Ltd. KPR Class II 1986-05-07
K853754 MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901 Victoreen, Inc. LHO Class I 1986-05-07
K854976 RMI RESPIRATORY GATING SYSTEM MODEL 301 Radiation Measurements, Inc. IXO Class I 1986-05-07
K860260 MULTI PURPOSE MODEL 76-903 Victoreen, Inc. LHO Class I 1986-05-07
K843247 KOI PACHYMETER Koi, Inc. ITX Class II 1986-04-30
K854590 HANDHELD DOPLER/PEN TRANSDUCER 3MHZ Philips Medical Systems, Inc. JAF Class II 1986-04-23
K854591 SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ Philips Medical Systems, Inc. JAF Class II 1986-04-23
K854499 GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR Gendex Corp. IZO Class I 1986-04-22
K854953 DIAMED MODELS 600, 900, 960, 964 Diamed Division Ill. Tool Works, Inc. JAA Class II 1986-04-22
K860100 MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902 Victoreen, Inc. LHO Class I 1986-04-22
K844772 6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU Philips Medical Systems, Inc. ITX Class II 1986-04-17

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