meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
35
Latest Decision
1995-05-12

Clearances · page 112 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K943798 MRH-1500 Hitachi Medical Systems America, Inc. LNH Class II 1995-05-12
K951315 CATHETERIZATION TABLE KS-60 Shimadzu Medical Systems IZZ Class II 1995-05-11
K941127 QCT-BONE MINERAL ANALYSIS SOFTWARE Image Analysis, Inc. KGI Class II 1995-05-11
K950980 FAST FIND GRID Webb Research, Inc. KPR Class II 1995-05-11
K936236 SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES Shimadzu Medical Systems JAA Class II 1995-05-11
K935994 PW DOPPLER VASCULAR PROBES Koven Technology, Inc. ITX Class II 1995-05-11
K946320 R 302 Ralco S.R.L. KPW Class II 1995-05-11
K950973 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE Medical Systems LNH Class II 1995-05-11
K944445 ED CORP RADIATION SCREEN Med Corp. EAK Class I 1995-05-11
K944046 FUJI COMPUTED RADIOGRAPHY SYSTEMS Fujifilm Medical System U.S.A., Inc. IXW Class II 1995-05-11
K951601 MED-TEC STRING RETICLE TRAY Medtec, Inc. IWE Class I 1995-05-11
K951765 SERIES 6600 DIGITAL MOBILE C-ARM Ge Dec Medical Systems OXO Class II 1995-05-11
K941191 REAL TIME STEREOTIX GE Medical Systems IZH Class II 1995-05-11
K945320 TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL Tetra Corp. ITX Class II 1995-05-11
K950043 JPI AUTOMATIC X-RAY FILM PROCESSOR Jpi Healthcare Co, Ltd. IXW Class II 1995-05-10
K950683 ARTHROGRAM TRAY Surgical Technologies, Inc. JAA Class II 1995-05-06
K926449 VARIAN MULTILEAF COLLIMATOR, RELEASE 4.0 Varian Assoc., Inc. IYE Class II 1995-05-05
K942504 INSTASPOT Fidelity Medical, Inc. LLZ Class II 1995-05-05
K945318 TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA Tetra Corp. ITX Class II 1995-05-05
K946378 BCM 400CP B C Medical , Ltd. IZI Class II 1995-05-04
K943156 SYSTEM, IMAGE PROCESSING Image Technology, Inc. JAA Class II 1995-05-04
K945319 TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENT Tetra Corp. ITX Class II 1995-05-04
K951372 PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) Philips Medical Systems, Inc. IZW Class II 1995-05-04
K951146 IMAGING TABLE Septa Corp. KXJ Class II 1995-05-04
K944004 VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) Endosonics Corp. IYO Class II 1995-05-04
K950431 LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM Open Mri, Inc. LMD Class I 1995-05-04
K941126 QCT-BONE MINERAL ANALYSIS PHANTOM Image Analysis, Inc. KGI Class II 1995-05-03
K950699 PREVIEW TELEIMAGING SYSTEM Regulatory Management Services LMD Class I 1995-05-03
K944978 BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI Bennett X-Ray Corp. IZH Class II 1995-05-03
K946114 SENSORI-MOTOR RATING SCALE Cmed IXY Class I 1995-04-28
K943623 PQ5000 CT SYSTEM Philips Medical Systems (Cleveland), Inc. JAK Class II 1995-04-27
K943596 VANTAGE, FOR ADAC GAMMA CAMERAS Adac Laboratories KPS Class II 1995-04-26
K930265 HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT GE Medical Systems LNI Class II 1995-04-25
K950610 FIKO FO;, TJER,A; O,AGER FTO-1000 Fujifilm Medical System U.S.A., Inc. LMC Class II 1995-04-25
K945526 LUNAR EXPERT Lunar Corp. KGI Class II 1995-04-25
K951176 KOORDINAT M Siemens Medical Solutions USA, Inc. IXR Class II 1995-04-20
K945875 MRT-50 QD BODY COIL Toshiba America Mri, Inc. LNH Class II 1995-04-20
K933512 UPSCAN Merlin Engineering Works, Inc. KPR Class II 1995-04-19
K945828 ECHO PLANAR IMAGING I Philips Medical Systems (Cleveland), Inc. LNH Class II 1995-04-12
K950343 HYPERPACS PACS AND TELERAFIOLOGY SYSTEM Rogan Imaging Corp. LMD Class I 1995-04-12
K940112 X-RAY FILM PROCESSOR Fischer Industries, Inc. IXW Class II 1995-04-11
K950971 MOBIL C-ARM, REGURBISHED, VARIOUS MODELS Pro-Tronics, Inc. JAA Class II 1995-04-11
K944610 OLYMPUS ULTRASONIC PROBES Olympus America, Inc. ITX Class II 1995-04-10
K951004 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) Kenex , Ltd. KPY Class I 1995-04-10
K940772 ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER) Fonar Corp. LNH Class II 1995-04-10
K945721 PENN-PET SCANNER Ugm Medical Systems, Inc. KPS Class II 1995-04-07
K950068 CARBON FIBER COUCH INSERT Medtec, Inc. KXJ Class II 1995-04-06
K951053 ANGIOREX CAT-350B Toshiba America Medical Systems, In.C IZZ Class II 1995-04-06
K945798 MRT-35A UPGRADE 8.0CD Toshiba America Mri, Inc. LNH Class II 1995-04-06
K945665 FLEXART(TM) QD C-SPINE COIL Toshiba America Mri, Inc. LNH Class II 1995-04-06
K950288 AUTOLASER MULTI FORMAT CAMERA Afp Imaging Corp. LMC Class II 1995-04-04
K951006 KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7) Kenex , Ltd. IXA Class II 1995-04-03
K945962 BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY Bennett X-Ray Corp. IZH Class II 1995-04-03
K951003 KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) Kenex , Ltd. KPY Class I 1995-04-03
K950883 POLYDOROS SX 65 AND 80 Siemens Medical Solutions USA, Inc. IZO Class I 1995-04-03
K950981 ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 Biodex Medical Systems, Inc. IXR Class II 1995-04-03
K950571 LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 Continental X-Ray Corp. IZF Class II 1995-03-31
K950442 INFRARED EXPOSURE HAND SWITCH Medical X-Ray Intl., Inc. KXJ Class II 1995-03-31
K950694 COMPACT-X Electromed Intl., Ltd. IZO Class I 1995-03-31
K941353 MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM Elscint, Inc. IZH Class II 1995-03-31
K945743 PREFERENCE MAMMOGRAPHY SYSTEM Philips Medical Systems (Cleveland), Inc. IZH Class II 1995-03-31
K946053 SIMVIEW(TM) 3000 Siemens Medical Solutions USA, Inc. KPQ Class II 1995-03-31
K945241 LORAD M-IV, LORAD M-IVI Lorad Corp. IZH Class II 1995-03-31
K950402 CORSINI 9090 C.A.T. DI Corsini G. & C. Spa IXR Class II 1995-03-31
K946260 NTBS-1417, 1436, TBS-1417 Scott Imaging Intl., Inc. IXY Class I 1995-03-31
K945652 ATTENUATION CORRECTION GE Medical Systems KPS Class II 1995-03-31
K950631 ID400 SERIES ARMBOARDS Image Diagnostics, Inc. JAA Class II 1995-03-24
K945619 ATHENA HFX Fischer Imaging Corp. IZH Class II 1995-03-23
K950291 DIGITAL 625HF Fischer Imaging Corp. IZO Class I 1995-03-23
K946334 GALEN Medimage, Inc. KPS Class II 1995-03-23
K945778 PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL Medical Advances, Inc. LNH Class II 1995-03-23
K950040 SII 525 APR Scott Imaging Intl., Inc. IZO Class I 1995-03-21
K945386 STRATIS Hitachi Medical Systems America, Inc. LNH Class II 1995-03-21
K945261 PRISM 1500XP NUCLEAR GAMMA CAMERA SYSTEM Ohio Imaging, Inc. KPS Class II 1995-03-21
K950041 SII 360 APR Scott Imaging Intl., Inc. IZO Class I 1995-03-21
K945858 X-RAY FILM CASSETTE J.P.I. Chicago Co. IXA Class II 1995-03-21
K945452 UD 150L-F Shimadzu Medical Systems IZO Class I 1995-03-21
K945453 UD 150L-R II Shimadzu Medical Systems IZO Class I 1995-03-21
K950358 KONICA SRX-201 AUTOMATIC X-RA FILM PROCESSOR Storch Amini & Munves PC IXW Class II 1995-03-17
K944442 GENERAL ELECTRIC AMX 110, AMX II AND AMX 3 Pro-Tronics, Inc. IZL Class II 1995-03-14
K945512 HRSW OPTION FOR CT TWIN FLASH Elscint, Inc. JAK Class II 1995-03-14
K945460 PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION Philips Medical Systems North America, Inc. JAA Class II 1995-03-14
K945475 FUJI MEDICAL LASER IMAGER FL-IM D Fujifilm Medical System U.S.A., Inc. LMC Class II 1995-03-09
K945428 SCRIBE(TM) DIAGNOSTIC IMAGING WORKSTATION Multi-Dimensional Imaging, Inc. LLZ Class II 1995-03-09
K946117 MEDICAL IMAGE MANAGEMENT SYSTEM (MIM) Siemens Medical Solutions Health Services Corporat LLZ Class II 1995-03-02
K942296 V5M Acuson Corp. ITX Class II 1995-03-02
K935595 ACUSON MODEL 3001 Acuson Corp. ITX Class II 1995-03-02
K950608 DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION Lorad Corp. IZH Class II 1995-03-02
K944048 ULTRASOUND 77030 IMAGING SYSTEM Hewlett-Packard Co. IYN Class II 1995-03-01
K945449 UNICATH LLU ANGIOGRAPHIC SYSTEM Xre Corp. IZI Class II 1995-02-27
K941917 FLUOROPLUA CARDIAC AND/OR INSTAVIEW Fidelity Medical, Inc. JAA Class II 1995-02-24
K944522 MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT Medical Device Technologies, Inc. IWJ Class I 1995-02-24
K944322 AT&T IMAGE SOLUTIONS PICASSO STILL-IMAGE PHONE SYSTEM At&T Image Solutions LMD Class I 1995-02-24
K921695 ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS Parker Laboratories, Inc. ITX Class II 1995-02-23
K942145 NON-UNIFORM ATTENUATION CORRECTION SYSTEM Siemens Medical Solutions USA, Inc. KPS Class II 1995-02-22
K944952 ANGIOGRAPHIC SYSTEM Acoma Medical Imaging, Inc. IZI Class II 1995-02-17
K945654 NICOM DIGITAL IMAGE MANAGER Camtronics, Ltd. LMB Class I 1995-02-17
K915691 FOCUS RTP Computerized Medical Systems, Inc. MUJ Class II 1995-02-16
K933117 IORT SYSTEM Northwest Medical Physics Center IYE Class II 1995-02-16
K945749 BENNETT X-RAY TOMOGRAPHY SYSTEM Bennett X-Ray Corp. IZF Class II 1995-02-15

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