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 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260114 | Align® Cover and Pad Guidance Tool | CIVCO Medical Instruments Co., Inc. | 2026-09-24 | Traditional | PDF ↗ |
| K261170 | BA-004CC | Fujifilm Corporation | 2026-08-12 | Traditional | PDF ↗ |
| K254143 | EM-TECH Passive Ultrasound Probe Strap | EM-TECH Solutions, Inc. | 2026-08-10 | Traditional | PDF ↗ |
| K260161 | SmartGuide Disposable Guides and Grids | UC-CARE , Ltd. | 2026-07-30 | Traditional | PDF ↗ |
| K262474 | ND Needle Guidance System | Accurate Access, LLC | 2026-07-27 | Traditional | PDF ↗ |
| K261014 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | 2026-07-24 | Traditional | PDF ↗ |
| K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | Olympus Medical Systems Corporation | 2025-09-18 | Traditional | PDF ↗ |
| K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | Olympus Medical Systems Corporation | 2025-07-11 | Traditional | PDF ↗ |
| K250524 | Mendaera Guidance System | Mendaera, Inc. | 2025-07-02 | Traditional | PDF ↗ |
| K250469 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | 2025-06-13 | Traditional | PDF ↗ |
| K241662 | Ultrasound Transducer Cover | Vitrolife Sweden AB | 2024-08-30 | Traditional | PDF ↗ |
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Parker Laboratories, Inc. | 2024-08-15 | Traditional | PDF ↗ |
| K241615 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2024-07-03 | Special | PDF ↗ |
| K233109 | TP Pivot Pro Needle Guide | Civco Medical Solutions | 2023-12-22 | Traditional | PDF ↗ |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | FUJIFILM Healthcare Americas Corporation | 2023-12-13 | Traditional | PDF ↗ |
| K231783 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2023-11-14 | Special | PDF ↗ |
| K223689 | Disposable Needle Guides and Grids | Advance Medical Designs, Inc. | 2023-08-02 | Traditional | PDF ↗ |
| K222460 | Intraoperative Ultrasound Probe Cover | Exact Medical Manufacturing | 2023-05-12 | Traditional | PDF ↗ |
| K221278 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2023-01-11 | Traditional | PDF ↗ |
| K222052 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2022-11-22 | Traditional | PDF ↗ |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe Covers | Global Protection Corp. | 2022-06-07 | Traditional | PDF ↗ |
| K211270 | CIV-Clear cover | CIVCO Medical Instruments Co., Inc. | 2021-09-13 | Traditional | PDF ↗ |
| K211969 | EMM Ultrasonic Transducer Cover | Exact Medical Manufacturing | 2021-08-13 | Traditional | PDF ↗ |
| K201425 | Disposable Intraoperative Probe (DIOP8) | Huntleigh Healthcare Limited | 2021-02-19 | Traditional | PDF ↗ |
| K202035 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-11-20 | Traditional | PDF ↗ |
| K191491 | EZ-Cover | Medxpress.Pro | 2020-06-05 | Traditional | PDF ↗ |
| K200733 | Opticross 35 15 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | 2020-04-17 | Special | PDF ↗ |
| K190802 | Envision ultrasound pad and cover | Civco Medical Solutions | 2019-05-24 | Traditional | PDF ↗ |
| K171272 | Cook-Swartz Doppler Flow Probe | Cook Incorporated | 2018-07-17 | Traditional | PDF ↗ |
| K180970 | Disposable guides KDNG00 | Koelis | 2018-07-10 | Traditional | PDF ↗ |
| K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range | Koelis | 2017-07-31 | Traditional | PDF ↗ |
| K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor | CIVCO Medical Instruments Co., Inc. | 2017-06-09 | Traditional | PDF ↗ |
| K170741 | GTK Disposable Needle Guides | Geotek Medikal Ltd Sti | 2017-06-01 | Traditional | PDF ↗ |
| K171348 | Pinpoint GT Needle Guide Kits | C.R. Bard, Inc. | 2017-05-22 | Special | PDF ↗ |
| K163502 | iSR'obot Biopsy Kit | Biobot Surgical Pte., Ltd. | 2017-05-16 | Traditional | PDF ↗ |
| K170338 | A-View | Stroke2prevent B.V. | 2017-05-16 | Traditional | PDF ↗ |
| K152126 | UST-5550-R; UST-5536-R; L43K | Hitachi Aloka Medical America, Inc. | 2016-08-17 | Traditional | PDF ↗ |
| K160806 | Verza Guidance System | CIVCO Medical Instruments Co., Inc. | 2016-08-05 | Traditional | PDF ↗ |
| K160414 | Precision Point Biopsy Needle Guide | Corbin Clinical Resources, LLC | 2016-08-01 | Traditional | PDF ↗ |
| K153212 | Sheathes Ultrasound Probe Covers | Sheathing Technologies, Inc. | 2016-03-04 | Traditional | PDF ↗ |
| K152403 | Permanent Sled Bag | Boston Scientific | 2015-09-22 | Special | PDF ↗ |
| K142618 | Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System | Hitachi Aloka Medical America, Inc. | 2014-10-16 | Special | PDF ↗ |
| K141334 | REUSABLE GUIDE | Koelis | 2014-07-11 | Traditional | PDF ↗ |
| K140854 | INTRA-OPERATIVE ULTRASOUND TRANSDUCER | Hitachi Aloka Medical, Ltd. | 2014-06-11 | Traditional | PDF ↗ |
| K141093 | 6VT-D ULTRASOUND TRANSDUCER | Ge Vingmed Ultrasound AS | 2014-05-15 | Traditional | PDF ↗ |
| K131161 | EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, | CIVCO Medical Instruments Co., Inc. | 2013-09-17 | Traditional | PDF ↗ |
| K131528 | NON-PYROGENIC ULTRASOUND TRANSDUCER COVER | CIVCO Medical Instruments Co., Inc. | 2013-06-11 | Traditional | PDF ↗ |
| K123424 | MDU5 PLUS STERILE BAG | Boston Scientific Corp | 2013-02-20 | Traditional | PDF ↗ |
| K122921 | C1-6-D ULTRASOUND TRANSDUCER | GE Healthcare | 2012-10-05 | Special | PDF ↗ |
| K122515 | C2-9-D ULTRASOUND TRANSDUCER | GE Healthcare | 2012-09-11 | Special | PDF ↗ |
| K121062 | VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM | Ge Medical System Israel , Ltd. | 2012-08-17 | Traditional | PDF ↗ |
| K121807 | V5MS TRANSDUCER | Siemens Medical Solutions USA, Inc. | 2012-07-10 | Special | PDF ↗ |
| K113832 | SONICEYE ULTRASOUND TRANSDUCER | Blacktoe Medical Iii, Inc. | 2012-03-06 | Abbreviated | PDF ↗ |
| K111426 | EUCLID (TM) TIER 1-GW ACCESS SYSTEM | Houston Medical Robotics | 2012-03-01 | Traditional | PDF ↗ |
| K120156 | PUREIMAGE ULTRASOUND TRANSMISSION GEL | Medline | 2012-02-08 | Traditional | PDF ↗ |
| K110752 | HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER | Highland Instruments | 2011-06-28 | Traditional | PDF ↗ |
| K101952 | KONIX ULTRASOUND GEL | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 2011-05-27 | Traditional | PDF ↗ |
| K111021 | CUBESCAN / BIOCON-700 | Mcube Technology Co., Ltd. | 2011-04-27 | Traditional | PDF ↗ |
| K110999 | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Edan Instruments, Inc. | 2011-04-26 | Traditional | PDF ↗ |
| K110920 | UF-760AG | Fukuda Denshi Co., Ltd. | 2011-04-08 | Traditional | PDF ↗ |
| K110202 | FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB | Fujifilm Medical System U.S.A., Inc. | 2011-02-08 | Traditional | PDF ↗ |
| K103629 | PET-512MC TRANSESOPHAGEAL TRANSDUCER | Toshiba America Medical Systems, In.C | 2011-02-02 | Traditional | PDF ↗ |
| K110020 | TERASON T3200 ULTRASOUND SYSTEM | Teratech Corp. | 2011-01-20 | Traditional | PDF ↗ |
| K103645 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM | Toshiba Medical Systems Corporation, Japan | 2011-01-12 | Special | PDF ↗ |
| K103722 | THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2011-01-05 | Traditional | PDF ↗ |
| K102865 | DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-11-03 | Special | PDF ↗ |
| K102041 | AIXPLORER | Supersonic Imagine | 2010-10-13 | Traditional | PDF ↗ |
| K101816 | STN PROBE | Summit Doppler Systems, Inc. | 2010-08-19 | Special | PDF ↗ |
| K101757 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM | Sonosite,Inc. | 2010-08-12 | Traditional | PDF ↗ |
| K101829 | THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2010-07-16 | Traditional | PDF ↗ |
| K101008 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY | Shantou Institute of Ultrasonic Instruments (Siui | 2010-06-08 | Traditional | PDF ↗ |
| K101041 | DC-7 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-04-30 | Traditional | PDF ↗ |
| K100204 | SONALIS | Smith Associates | 2010-02-19 | Traditional | PDF ↗ |
| K100067 | MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM | Toshiba America Medical Systems, In.C | 2010-01-28 | Traditional | PDF ↗ |
| K093713 | ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM | Civco Medical Instruments | 2010-01-19 | Traditional | PDF ↗ |
| K093714 | SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2009-12-10 | Traditional | PDF ↗ |
| K093462 | SONIX ULTRASOUND SCANNER | Ultrasonix Medical Corporation | 2009-11-20 | Traditional | PDF ↗ |
| K092858 | SAFERSONIC SONOGRAPHY COVER | Safersonic Medizinprodukte GmbH | 2009-11-10 | Traditional | PDF ↗ |
| K092691 | DC-7 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009-10-15 | Traditional | PDF ↗ |
| K091828 | SHEATHESISO ULTRASOUND TRANSDUCER COVER | Sheathing Technologies, Inc. | 2009-09-28 | Traditional | PDF ↗ |
| K092756 | GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM | Ge Vingmed Ultrasound AS | 2009-09-28 | Traditional | PDF ↗ |
| K092637 | PACSCAN PLUS, MODELS 300P AND 300AP | Sonomed, Inc. | 2009-09-24 | Special | PDF ↗ |
| K091877 | CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL | Chison Medical Imaging Co., Ltd. | 2009-09-02 | Traditional | PDF ↗ |
| K091804 | CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS | Philips Ultrasound, Inc. | 2009-07-17 | Traditional | PDF ↗ |
| K091941 | DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009-07-09 | Traditional | PDF ↗ |
| K091680 | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Edan Instruments, Inc. | 2009-06-19 | Traditional | PDF ↗ |
| K091295 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 | Toshiba America Medical Systems, In.C | 2009-05-15 | Traditional | PDF ↗ |
| K090912 | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009-04-15 | Traditional | PDF ↗ |
| K090465 | DIGDOP ULTRASOUND SYSTEM | The Newman Group, LLC | 2009-04-08 | Traditional | PDF ↗ |
| K083824 | HUMANSCAN M5S-D ULTRASOUND TRANSDUCER | Humanscan Company, Ltd. | 2009-02-10 | Traditional | PDF ↗ |
| K083667 | NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 | B-K Medical Aps | 2009-02-02 | Traditional | PDF ↗ |
| K083877 | FLYING DIAGNOSTIC ULTRASOUND SYSTEM | Neusoft Medical Systems Co., Ltd. | 2009-01-13 | Traditional | PDF ↗ |
| K082224 | DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC | Shimadzu Medical Systems | 2008-12-15 | Traditional | PDF ↗ |
| K082893 | PRAGER SHELL | Esi, Inc. | 2008-12-05 | Traditional | PDF ↗ |
| K081919 | UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM | Fukuda Denshi Co., Ltd. | 2008-09-09 | Special | PDF ↗ |
| K081802 | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2008-07-11 | Traditional | PDF ↗ |
| K080970 | USHIFU STEPPER | Ushifu Development Company, LLC | 2008-06-11 | Traditional | PDF ↗ |
| K080555 | SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) | Ivu Imaging Corporation | 2008-06-03 | Traditional | PDF ↗ |
| K073623 | ATLANTIS 018 PERIPHERAL IMAGING CATHETER | Boston Scientific Corp | 2008-03-13 | Traditional | PDF ↗ |
| K080272 | ATLANTIS PVIMAGING CATHETER, MODEL H749364560 | Boston Scientific Corp | 2008-03-11 | Traditional | PDF ↗ |
Product code ITX · Class II · Radiology. Data: openFDA.