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 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K955668 | INTRACAVITY NEEDLE GUIDE KIT | Arlanda Medicinska Instrument Co. AB | 1997-07-30 | Traditional | PDF ↗ |
| K972672 | BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY | Barzell-Whitmore Maroon Bells, Inc. | 1997-07-29 | Traditional | PDF ↗ |
| K972348 | HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM | Hewlett-Packard Co. | 1997-07-24 | Traditional | PDF ↗ |
| K971942 | SLED, FINGER, HANDLE | Biosound Esaote, Inc. | 1997-07-23 | Traditional | PDF ↗ |
| K971722 | TRANS VAGINAL NEEDLE GUIDE | Protek Medical Products, Inc. | 1997-07-10 | Traditional | PDF ↗ |
| K971700 | BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER | Biosound, Inc. | 1997-07-09 | Traditional | PDF ↗ |
| K970515 | GENERAL PURPOSE LATEX TRANSDUCER COVERS | CIVCO Medical Instruments Co., Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K970514 | DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE | CIVCO Medical Instruments Co., Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K970513 | GENERAL PURPOSE TRANDUCER COVER | CIVCO Medical Instruments Co., Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K970049 | BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/ | Cardiovascular Imaging Systems, Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K971115 | GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE | Protek Medical Products, Inc. | 1997-06-13 | Traditional | PDF ↗ |
| K964549 | ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER | Aloka Co., Ltd. | 1997-06-03 | Traditional | PDF ↗ |
| K963989 | P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE | Cardiovascular Dynamics, Inc. | 1997-04-24 | Traditional | PDF ↗ |
| K970034 | SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM | Hewlett-Packard Co. | 1997-03-17 | Traditional | PDF ↗ |
| K964865 | PVK-720ST ENDOCAVITARY TRANSDUCER | Toshiba America Medical Systems, In.C | 1997-03-10 | Traditional | PDF ↗ |
| K970047 | PHASED ARRAY TRANSDUCER - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997-03-04 | Traditional | PDF ↗ |
| K964658 | OASIS | Sonotech, Inc. | 1997-02-14 | Traditional | PDF ↗ |
| K963831 | SHEATHES (NON-LATEX) | Medical Resources | 1997-02-10 | Traditional | PDF ↗ |
| K961974 | FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE | Pentax Precision Instrument Corp. | 1997-02-10 | Traditional | PDF ↗ |
| K963302 | TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM | Tayman Medical, Inc. | 1997-02-06 | Traditional | PDF ↗ |
| K961002 | DIASONICS ITNRAOPERATIVE PROBES | Diasonics Ultrasound | 1997-01-22 | Traditional | PDF ↗ |
| K962093 | ULTRAMIX | Sonotech, Inc. | 1996-12-23 | Traditional | PDF ↗ |
| K962840 | ECOLOTION TRANSMISSION AND MASSAGE LOTION | Eco-Med Pharmaceuticals, Inc. | 1996-12-23 | Traditional | PDF ↗ |
| K963169 | RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL | Rapid-Aid Ltd./Ltee | 1996-11-12 | Traditional | PDF ↗ |
| K951567 | CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE | Cardio Metrics, Inc. | 1996-10-25 | Traditional | PDF ↗ |
| K962293 | ENDOSONICS AUTOMATIC PULL BACK DEVICE | Endosonics Corp. | 1996-09-16 | Traditional | PDF ↗ |
| K961692 | SONOSCAN | Sonotech, Inc. | 1996-08-22 | Traditional | PDF ↗ |
| K961757 | ECOGEL 100 ULTRASOUND GEL | Eco-Med Pharmaceuticals, Inc. | 1996-07-25 | Traditional | PDF ↗ |
| K953716 | INTRACAVITY TRANSDUCERS | Biosound, Inc. | 1996-04-17 | Traditional | PDF ↗ |
| K953759 | DIAGNOSTIC ULTRASOUND TRANSDUCER | Biosound, Inc. | 1996-03-01 | Traditional | PDF ↗ |
| K953819 | DIAGNOSTIC ULTRASOUND TRANDUCER | Biosound, Inc. | 1996-03-01 | Traditional | PDF ↗ |
| K955246 | ECOGEL 200 ULTRASOUND GEL | Eco-Med Pharmaceuticals, Inc. | 1996-02-21 | Traditional | PDF ↗ |
| K952892 | OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) | Olympus America, Inc. | 1996-02-12 | Traditional | PDF ↗ |
| K955458 | ULTRASOUND PROBE BIOPSY ACCESSORIES | Biosound, Inc. | 1996-02-12 | Traditional | PDF ↗ |
| K953579 | TEE PROBE | Biosound, Inc. | 1996-02-02 | Traditional | PDF ↗ |
| K951723 | GE B510 TRANSDUCER | GE Medical Systems | 1995-11-14 | Traditional | PDF ↗ |
| K953430 | ULTRASOUND PROBE BIOPSY ACCESSORIES | Biosound, Inc. | 1995-10-24 | Traditional | PDF ↗ |
| K941935 | LP-12 LAPAROSCOPIC PROBE | Biosound, Inc. | 1995-09-18 | Traditional | PDF ↗ |
| K946300 | DOPPLEX SURGICAL PROBES | Hne Healthcare, Inc. | 1995-07-26 | Traditional | PDF ↗ |
| K951145 | VMI 1000 SURGICAL PACEOMETER | Vision Medical Instruments, Inc. | 1995-06-19 | Traditional | PDF ↗ |
| K944017 | OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM | Olympus America, Inc. | 1995-06-13 | Traditional | PDF ↗ |
| K944287 | 7050 ULTRASOUND IMAGING SYSTEM | Biosound, Inc. | 1995-06-02 | Traditional | PDF ↗ |
| K945796 | SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM | Sharplan Lasers, Inc. | 1995-05-24 | Traditional | PDF ↗ |
| K935994 | PW DOPPLER VASCULAR PROBES | Koven Technology, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K945320 | TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL | Tetra Corp. | 1995-05-11 | Traditional | PDF ↗ |
| K945318 | TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA | Tetra Corp. | 1995-05-05 | Traditional | PDF ↗ |
| K945319 | TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENT | Tetra Corp. | 1995-05-04 | Traditional | PDF ↗ |
| K944610 | OLYMPUS ULTRASONIC PROBES | Olympus America, Inc. | 1995-04-10 | Traditional | PDF ↗ |
| K942296 | V5M | Acuson Corp. | 1995-03-02 | Traditional | PDF ↗ |
| K935595 | ACUSON MODEL 3001 | Acuson Corp. | 1995-03-02 | Traditional | PDF ↗ |
| K921695 | ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS | Parker Laboratories, Inc. | 1995-02-23 | Traditional | PDF ↗ |
| K930052 | SIEMENS QUANTUM 7E11 TRANSRECTAL TRANSDUCER | Siemens Quantum, Inc. | 1995-01-04 | Traditional | PDF ↗ |
| K943637 | SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM | Aloka Co., Ltd. | 1994-12-29 | Traditional | PDF ↗ |
| K940108 | DIAGNOSTIC ULTRASOUND IMAGING CATHETER | Boston Scientific Corp | 1994-12-07 | Traditional | PDF ↗ |
| K940671 | INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER | Interspec, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K940804 | SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION | Peripheral Systems Group | 1994-06-10 | Traditional | PDF ↗ |
| K933663 | MODIFICATION OF ACUSON V510B TRANSDUCER | Acuson Corp. | 1994-01-21 | Traditional | PDF ↗ |
| K925869 | SHEATHES, STERILE SHEATHES | Mayer Laboratories | 1994-01-06 | Traditional | PDF ↗ |
| K932777 | SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER | Peripheral Systems Group | 1993-10-07 | Traditional | PDF ↗ |
| K925434 | SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A | Kretz Technik | 1993-09-30 | Traditional | PDF ↗ |
| K932536 | CARDIOMETRICS FLOWIRE & FLOMAP | Cardio Metrics, Inc. | 1993-09-28 | Traditional | PDF ↗ |
| K925081 | SURFAS | D.O. Weaver and Co. | 1993-09-28 | Traditional | PDF ↗ |
| K926108 | VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800 | Vingmed Sound, Inc. | 1993-09-24 | Traditional | PDF ↗ |
| K920882 | ACUSON V714 TRANSDUCER | Acuson Corp. | 1993-03-26 | Traditional | PDF ↗ |
| K925486 | UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS. | Aloka Co., Ltd. | 1993-02-12 | Traditional | PDF ↗ |
| K924980 | CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH | Endosonics Corp. | 1993-01-15 | Traditional | PDF ↗ |
| K923348 | OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED | Zeiss Humphrey System | 1992-12-10 | Traditional | PDF ↗ |
| K921341 | ACUSON V714OR TRANSDUCER | Acuson Corp. | 1992-11-27 | Traditional | PDF ↗ |
| K915696 | INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE | Interspec, Inc. | 1992-11-24 | Traditional | PDF ↗ |
| K913890 | SONICATH(TM) 3.5 F, 20 MHZ | Boston Scientific Corp | 1992-11-09 | Traditional | PDF ↗ |
| K915647 | DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250 | Pie Medical Equipment B.V. | 1992-11-09 | Traditional | PDF ↗ |
| K922549 | UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35 | Aloka Co., Ltd. | 1992-09-21 | Traditional | PDF ↗ |
| K911435 | CPA/3.5 MHZ PROBE | Diasonics, Inc. | 1992-09-11 | Traditional | PDF ↗ |
| K902515 | ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP | Acuson Corp. | 1992-09-04 | Traditional | PDF ↗ |
| K912364 | ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED | Hitachi Medical Corp. of America | 1992-08-26 | Traditional | PDF ↗ |
| K922184 | HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM | Hewlett-Packard Co. | 1992-07-30 | Traditional | PDF ↗ |
| K921750 | CVIS INSIGHT III SYSTEM | Cardiovascular Imaging Systems, Inc. | 1992-07-13 | Traditional | PDF ↗ |
| K915860 | LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE | Biosound, Inc. | 1992-07-02 | Traditional | PDF ↗ |
| K921631 | CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL | Cardiovascular Imaging Systems, Inc. | 1992-07-02 | Traditional | PDF ↗ |
| K921563 | CARDIOMETRICS FLOWIRE/FLOMAP SYSTEM | Cardio Metrics, Inc. | 1992-07-01 | Traditional | PDF ↗ |
| K911916 | ACUSON C366 TRANSDUCER | Acuson Corp. | 1992-06-18 | Traditional | PDF ↗ |
| K921148 | CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE | Cardiovascular Imaging Systems, Inc. | 1992-06-16 | Traditional | PDF ↗ |
| K921147 | CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE | Cardiovascular Imaging Systems, Inc. | 1992-06-16 | Traditional | PDF ↗ |
| K921036 | SONOS 100 ULTRASOUND IMAGING SYSTEM | Hewlett-Packard Co. | 1992-05-29 | Traditional | PDF ↗ |
| K920307 | AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION | Ausonics Pty , Ltd. | 1992-05-19 | Traditional | PDF ↗ |
| K910966 | SECTOR TRANSDUCER MODEL NO. AWP3.5/A | Kretztechnik AG | 1992-04-17 | Traditional | PDF ↗ |
| K905200 | SACA, 3.5 MHZ PROBE | Diasonics, Inc. | 1992-04-02 | Traditional | PDF ↗ |
| K920678 | ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER | Interspec, Inc. | 1992-04-02 | Traditional | PDF ↗ |
| K914006 | BIPLANE TRANSRECTAL PROBE | Biosound, Inc. | 1992-04-02 | Traditional | PDF ↗ |
| K913798 | SONOLAYER ALPHA, MODEL SSH-140A | Toshiba America Medical Systems, In.C | 1992-04-01 | Traditional | PDF ↗ |
| K913472 | LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM | Baxter Healthcare Corp | 1992-03-13 | Traditional | PDF ↗ |
| K903562 | CW DOPPLER 2.25 MHZ PROBE | Diasonics, Inc. | 1992-03-02 | Traditional | PDF ↗ |
| K913941 | PSG(TM) 20 GUAGE DOPPLER NEEDLE | Peripheral Systems Group | 1992-02-27 | Traditional | PDF ↗ |
| K910850 | PSF-50ET | Toshiba America Medical Systems, In.C | 1992-01-29 | Traditional | PDF ↗ |
| K912776 | CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUND | Cardio Metrics, Inc. | 1992-01-09 | Traditional | PDF ↗ |
| K911116 | INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYST | Interson Corp. | 1991-12-20 | Traditional | PDF ↗ |
| K911115 | INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM | Interson Corp. | 1991-12-17 | Traditional | PDF ↗ |
| K911113 | INTERSON TRANSRECTAL PROBE/KONTRON ULTRASOUND SYST | Interson Corp. | 1991-12-17 | Traditional | PDF ↗ |
| K913746 | SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM | Peripheral Systems Group | 1991-12-17 | Traditional | PDF ↗ |
| K911117 | INTERSON ENDOCAVITY PROBE FOR ATL ULTRASOUND SYST | Interson Corp. | 1991-12-17 | Traditional | PDF ↗ |
Product code ITX · Class II · Radiology. Data: openFDA.