FDA Product Code
FDA Product Code ITX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1570
510(k) Clearances — 415 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K080119 | CLEARSCAN | Esi, Inc. | 2008-02-21 | Traditional | PDF ↗ |
| K071289 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | Shimadzu Medical Systems | 2008-01-09 | Traditional | PDF ↗ |
| K071291 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | Shimadzu Medical Systems | 2008-01-09 | Traditional | PDF ↗ |
| K071287 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO | Shimadzu Medical Systems | 2008-01-09 | Traditional | PDF ↗ |
| K072786 | ACUSON S2000 ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2007-11-13 | Traditional | PDF ↗ |
| K072918 | MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 | Toshibamedical Systems Corporation | 2007-10-29 | Traditional | PDF ↗ |
| K072826 | APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM | Toshiba America Medical Systems, In.C | 2007-10-24 | Traditional | PDF ↗ |
| K070195 | BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B | Broadsound Corporation | 2007-10-15 | Abbreviated | PDF ↗ |
| K072541 | SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM | Senorx, Inc. | 2007-09-25 | Traditional | PDF ↗ |
| K072164 | DC-6 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007-09-05 | Traditional | PDF ↗ |
| K072285 | ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM | Aloka Co., Ltd. | 2007-08-30 | Traditional | PDF ↗ |
| K072266 | ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2007-08-29 | Traditional | PDF ↗ |
| K070515 | A-VIEW BASIC AND PLUS | Cordatec N.V. | 2007-07-30 | Traditional | PDF ↗ |
| K070903 | MYLAB40 | Esaote Europe B.V. | 2007-07-02 | Traditional | PDF ↗ |
| K061153 | GYNESONICS EC6 TRANSDUCER | Gynesonics, Inc. | 2006-10-27 | Traditional | PDF ↗ |
| K061560 | SONOMARK | Medical Products Manufacturing, Inc. | 2006-08-18 | Traditional | PDF ↗ |
| K060947 | SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020 | Boston Scientific Corp | 2006-04-19 | Special | PDF ↗ |
| K060879 | MODEL EC9-4 TRANSDUCER | Siemens Medical Solutions USA, Inc. | 2006-04-19 | Special | PDF ↗ |
| K053463 | AIM ACCURACY IN MARKING SYSTEM | Georgene Austria | 2006-03-07 | Traditional | PDF ↗ |
| K052517 | SITE-RITE 5 ULTRASOUND SYSTEM | C.R. Bard, Inc. | 2005-09-29 | Traditional | PDF ↗ |
| K052021 | V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER | Siemens Medical Solutions USA, Inc. | 2005-08-17 | Special | PDF ↗ |
| K050320 | FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT | Ascendia Medtech AB | 2005-08-15 | Traditional | PDF ↗ |
| K050724 | SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM | C.R. Bard, Inc. | 2005-04-18 | Special | PDF ↗ |
| K043425 | SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) | Sheathing Technologies, Inc. | 2005-02-28 | Traditional | PDF ↗ |
| K043278 | TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES | Teratech Corp. | 2004-12-13 | Traditional | PDF ↗ |
| K032315 | IOP8 INTRA OPERATIVE PROBE | Huntleigh Healthcare, Inc. | 2004-11-18 | Traditional | PDF ↗ |
| K041818 | SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020 | Boston Scientific Corp | 2004-11-10 | Special | PDF ↗ |
| K042445 | SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT | Bard Access Systems, Inc. | 2004-10-19 | Traditional | PDF ↗ |
| K040213 | MHLX7EC TRANSDUCER | Microhelix, Inc. | 2004-09-22 | Traditional | PDF ↗ |
| K041638 | TARGETSCAN BIOPSY KIT | Envisioneering, LLC | 2004-09-02 | Traditional | PDF ↗ |
| K041637 | TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM | Envisioneering, LLC | 2004-09-01 | Traditional | PDF ↗ |
| K041395 | EG-3630UR | Pentax Precision Instrument Corp. | 2004-06-09 | Traditional | PDF ↗ |
| K041396 | FG-36UX FIBER ULTRASOUND GASTROSCOPE | Pentax Precision Instrument Corp. | 2004-06-09 | Traditional | PDF ↗ |
| K041397 | EG-3830UT | Pentax Precision Instrument Corp. | 2004-06-09 | Traditional | PDF ↗ |
| K040840 | TERATECH MODEL 10V5 SMART PROBE | Teratech Corp. | 2004-04-14 | Traditional | PDF ↗ |
| K022156 | LATEX ULTRASONIC PROBE COVER | Pleasure Latex Products Sdn. Bhd. | 2003-09-11 | Abbreviated | PDF ↗ |
| K031920 | CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 | Trans Vascular Incorporated | 2003-07-23 | Special | PDF ↗ |
| K030518 | AMERITEK SURE-POINT TRACKER SYSTEM | Amertek Medical, Inc. | 2003-05-20 | Traditional | PDF ↗ |
| K031358 | TRANSVAGINAL DOPPLER PROBE | Vascular Control Systems, Inc. | 2003-05-09 | Traditional | PDF ↗ |
| K030064 | ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY | Sonosite,Inc. | 2003-01-22 | Traditional | PDF ↗ |
| K022860 | ATLANTIS PV IMAGING CATHETER, MODEL 36456 | Boston Scientific, Target | 2002-11-21 | Special | PDF ↗ |
| K023024 | TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 | Vascular Control Systems, Inc. | 2002-09-26 | Traditional | PDF ↗ |
| K022649 | COOK-SWARTZ DOPPLER FLOW PROBE | Cook Vascular, Inc. | 2002-09-06 | Special | PDF ↗ |
| K013363 | CROSSPOINT TRANSACCESS CATHETER | Trans Vascular Incorporated | 2002-04-02 | Traditional | PDF ↗ |
| K013723 | MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER | Hitachi Medical Corp. | 2002-02-06 | Special | PDF ↗ |
| K014182 | TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS | Tetrad Corp. | 2002-01-03 | Traditional | PDF ↗ |
| K013721 | SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER | CIVCO Medical Instruments Co., Inc. | 2001-12-28 | Traditional | PDF ↗ |
| K002958 | SHAPEABLE DOPPLER FLOW PROBE | Cook Vascular, Inc. | 2001-12-18 | Traditional | PDF ↗ |
| K013849 | TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS | Tetrad Corp. | 2001-12-03 | Traditional | PDF ↗ |
| K013170 | SCANTAC MEMBRANE OR SCANTAC STRIP | Sonotech, Inc. | 2001-11-13 | Traditional | PDF ↗ |
| K011265 | ULTRASOUND TRANSDUCER COVER | Advance Medical Designs, Inc. | 2001-10-30 | Traditional | PDF ↗ |
| K012522 | WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL | National Therapy Products, Inc. | 2001-10-18 | Traditional | PDF ↗ |
| K011581 | AMERITEK BRACHYTHERAPY TEMPLATE | Amertek Medical, Inc. | 2001-07-17 | Traditional | PDF ↗ |
| K011284 | THIN FILM DRESSING FOR ULTRASOUND EXAM | Martin E. Wendelken | 2001-06-20 | Traditional | PDF ↗ |
| K011314 | OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM | Aloka Co., Ltd. | 2001-05-15 | Traditional | PDF ↗ |
| K002193 | TETRAD TC-C3-ACP | Tetrad Corp. | 2001-05-04 | Traditional | PDF ↗ |
| K010883 | TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE | Teratech Corp. | 2001-04-06 | Traditional | PDF ↗ |
| K002856 | AT3C70 TRANSDUCER | Sonora Medical Systems | 2001-04-02 | Abbreviated | PDF ↗ |
| K002784 | ALOKA UST-5280-5 | Aloka Co., Ltd. | 2000-09-20 | Traditional | PDF ↗ |
| K994103 | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT | Olympus America, Inc. | 2000-09-05 | Traditional | PDF ↗ |
| K994069 | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE | Olympus America, Inc. | 2000-06-02 | Traditional | PDF ↗ |
| K994106 | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE | Olympus America, Inc. | 2000-06-02 | Traditional | PDF ↗ |
| K001203 | OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT | The Olympus Optical Co. | 2000-05-26 | Traditional | PDF ↗ |
| K992178 | BALLOON FOR ULTRASONIC ENDOSCOPES | N.M. Beale Co., Inc. | 2000-05-12 | Traditional | PDF ↗ |
| K001016 | GE LOGIQ 700 | GE Medical Systems | 2000-04-24 | Special | PDF ↗ |
| K994373 | HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4) | Atl Ultrasound, Inc. | 2000-03-24 | Traditional | PDF ↗ |
| K992305 | MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 | Medi-Stim A/S | 1999-09-08 | Traditional | PDF ↗ |
| K982208 | IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER | Jomed Imaging , Ltd. | 1999-08-27 | Traditional | PDF ↗ |
| K992152 | GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF | CIVCO Medical Instruments Co., Inc. | 1999-08-17 | Traditional | PDF ↗ |
| K984639 | THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER | Medison America, Inc. | 1999-07-12 | Traditional | PDF ↗ |
| K992155 | VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7 | Medison America, Inc. | 1999-07-08 | Traditional | PDF ↗ |
| K984562 | VIVOSONIC | Sonotech, Inc. | 1999-06-08 | Traditional | PDF ↗ |
| K991236 | GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER, | CIVCO Medical Instruments Co., Inc. | 1999-06-02 | Traditional | PDF ↗ |
| K983691 | SCANFLEX SOLID COUPLANT MEMBRANE | Sonotech, Inc. | 1999-05-05 | Traditional | PDF ↗ |
| K990175 | SHEATHES (NON-LATEX), STERILE | Sheathing Technologies, Inc. | 1999-04-21 | Traditional | PDF ↗ |
| K983985 | HYBRISONIC SHEATH | Sonotech, Inc. | 1999-02-25 | Traditional | PDF ↗ |
| K990400 | LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM | Hewlett-Packard Co. | 1999-02-24 | Traditional | PDF ↗ |
| K982568 | BLADDERMANAGER PCI 5000 MODEL 1002 | Diagnostic Ultrasound Corp. | 1999-01-25 | Traditional | PDF ↗ |
| K982329 | VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900) | Endosonics Corp. | 1999-01-14 | Traditional | PDF ↗ |
| K982323 | OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE | Olympus America, Inc. | 1998-12-11 | Traditional | PDF ↗ |
| K982610 | OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT) | Olympus Optical, Co. | 1998-11-16 | Traditional | PDF ↗ |
| K982733 | OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE | The Olympus Optical Co. | 1998-10-28 | Traditional | PDF ↗ |
| K982725 | OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE | Olympus America, Inc. | 1998-10-23 | Traditional | PDF ↗ |
| K981069 | ULTRA-COVER PU-TRANSDUCER COVER | International Medical Products B.V. | 1998-09-23 | Traditional | PDF ↗ |
| K981028 | ULTRA IMAGE AND ULTRA SCAN | Sonotech, Inc. | 1998-08-21 | Traditional | PDF ↗ |
| K981434 | EUP-OL334 LAPARASCOPICPROBE | Hitachi Medical Corp. of America | 1998-07-27 | Traditional | PDF ↗ |
| K964001 | SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM | Med Institute, Inc. | 1998-04-17 | Traditional | PDF ↗ |
| K980091 | LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60 | Cosmaceutical Marketing, Inc. | 1998-04-09 | Traditional | PDF ↗ |
| K974544 | ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER | Aloka Co., Ltd. | 1998-03-18 | Traditional | PDF ↗ |
| K972771 | PHASED ARRAY TRANSDUCER - - PVF -375DT | Toshiba America Medical Systems, In.C | 1998-02-11 | Traditional | PDF ↗ |
| K974301 | CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER | Clk Intl., Inc. | 1998-02-06 | Traditional | PDF ↗ |
| K973713 | 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR | Cardiovascular Dynamics, Inc. | 1998-01-23 | Traditional | PDF ↗ |
| K973958 | GENERAL PURPOSE ATL NEEDLE GUIDE KIT | Protek Medical Products, Inc. | 1998-01-22 | Traditional | PDF ↗ |
| K971116 | SONOS 5500 IMAGING SYSTEM | Hewlett-Packard Co. | 1998-01-12 | Traditional | PDF ↗ |
| K955893 | EVERYTIME TRANSFUCER COVER | Amedic AB | 1997-12-30 | Traditional | PDF ↗ |
| K973622 | TRANSDUCER POSITIONER | Protek Medical Products, Inc. | 1997-11-26 | Traditional | PDF ↗ |
| K973079 | L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM | Acuson Corp. | 1997-11-05 | Traditional | PDF ↗ |
| K973362 | NEEDLE GUIDE/GRID | Protek Medical Products, Inc. | 1997-10-01 | Traditional | PDF ↗ |
| K971397 | VIEWCATH 3-D CATHETER PULLBACK | Quinton, Inc. | 1997-08-25 | Traditional | PDF ↗ |
| K972152 | DEVMED STEPPING AND STABILIZING SYSTEM | Devmed Corp. | 1997-08-15 | Traditional | PDF ↗ |
Product code ITX · Class II · Radiology. Data: openFDA.