Data / Medical devices / United States / Fujifilm Sonosite,inc.
Fujifilm Sonosite,inc.: FDA-registered device maker in Bothell, WA, United States, 36 510(k) clearances
Fujifilm Sonosite,inc. is registered with the FDA (registration 3032367) in Bothell, WA, United States. It lists 8 device types. The FDA files 36 510(k) clearances under its listings, the newest dated March 10, 2026. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032367
- FEI number
- 3002087856
- Address
- 21919 30th Dr SE, Bothell, WA, United States, 98021
- Owner or operator
- FUJIFILM CORPORATION (8031568)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Specification developer
- First device listed
- October 23, 2013
- Registered through
- 2026
- Brand names listed
- Axo Track, Bio Z Cardio Profile, C10-3 MHz Transducer, C5-1 MHz Transducer, Cable, Leadwires, ECG, Edge Ultrasound System, Exact Track, External ECG Connector Cable and Adapter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Biopsy Needle Guide Kit | OIJ | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Plethysmograph, Impedance | DSB | 2 | Remanufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 10, 2026 | K260595 | Sonosite iLOOK Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| November 3, 2025 | K253448 | Sonosite MT Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| August 29, 2025 | K251106 | Sonosite LX and Sonosite PX Ultrasound Systems | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| July 10, 2025 | K251830 | Sonosite LX Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| December 6, 2023 | K233597 | Sonosite LX Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| December 27, 2021 | K213763 | Sonosite PX Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| May 8, 2020 | K200964 | Sonosite PX Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| March 15, 2019 | K190476 | FUJIFILM Sonosite Vevo MD Imaging System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| February 7, 2019 | K183235 | SonoSite SII Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| April 13, 2018 | K180704 | SonoSite iViz Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| June 12, 2017 | K171437 | SonoSite X-Porte Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| September 8, 2016 | K162288 | SonoSite iViz Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| August 18, 2016 | K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| May 13, 2016 | K161119 | SonoSite iViz Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| April 19, 2016 | K160674 | Fujifilm Sonosite Vevo MD Imaging System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| April 5, 2016 | K160734 | SonoSite SII Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| March 16, 2016 | K160406 | FUJIFILM FC1 Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| January 20, 2016 | K153626 | SonoSite Edge II Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| November 12, 2015 | K152983 | FUJIFILM SonoSite iViz Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| August 19, 2015 | K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| August 22, 2014 | K142017 | X-PORTE ULTRASOUND SYSTEM | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| December 16, 2013 | K133454 | SONOSITE EDGE ULTRASOUND SYSTEM | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| November 4, 2013 | K133134 | X-PORTE ULTRASOUND SYSTEM | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| March 25, 2013 | K130173 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| December 29, 2011 | K113680 | SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT | IYO | Substantially Equivalent | Soma Access Systems, LLC | accessdata.fda.gov |
| November 15, 2011 | K113156 | SONOSITE EDGE ULTRASOUND SYSTEM | IYO | Substantially Equivalent | Sonosite,Inc. | accessdata.fda.gov |
| June 3, 2011 | K110645 | BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR | DSB | Substantially Equivalent | Sonosite,Inc. | accessdata.fda.gov |
| November 19, 2010 | K102390 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Sonosite,Inc. | accessdata.fda.gov |
| August 12, 2010 | K101757 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM | ITX | Substantially Equivalent | Sonosite,Inc. | accessdata.fda.gov |
| October 2, 2009 | K092058 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Sonosite,Inc. | accessdata.fda.gov |
| August 25, 2008 | K082098 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Sonosite,Inc. | accessdata.fda.gov |
| May 8, 2007 | K071134 | SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | Sonosite,Inc. | accessdata.fda.gov |
| November 16, 2005 | K053069 | SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | IYN | Substantially Equivalent | Sonosite,Inc. | accessdata.fda.gov |
| January 12, 2005 | K043559 | SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | IYN | Substantially Equivalent | Sonosite,Inc. | accessdata.fda.gov |
| December 21, 2004 | K043452 | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Sonosite,Inc. | accessdata.fda.gov |
| January 22, 2003 | K030064 | ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY | ITX | Substantially Equivalent | Sonosite,Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 11, 2013 | 66346 | Class II | Terminated | P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Techno | FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended. | accessdata.fda.gov |
| July 18, 2011 | 59442 | Not yet classified | Terminated | MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic Ultrasound. General purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow a | This is a software anomaly. In some circumstances, if the Systolic/Diastolic (S/D) ratio value is interpreted directly from the display, the clinician could potentially use an incorrect value of the S/D ratio in his/her assessment. | accessdata.fda.gov |
| August 13, 2010 | 56428 | Not yet classified | Terminated | The software is ARM version 60.80. (referred to as Nano 1.0.5). The software is used with the SonoSite NanoMaxx ultrasound system. | Software ARM version 60.80. (referred to as Nano1.0.5) on the NanoMaxx ultrasound system results in errors when the "print" command is selected. As a result, the displayed MI or TI values may be incorrect. | accessdata.fda.gov |
| May 27, 2010 | 55874 | Not yet classified | Terminated | PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted assembly (P12822) and a docking assembly (P12834). The stand mounted assembly is mounted to the V or H Universal stand | PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment. | accessdata.fda.gov |
| August 8, 2008 | 49374 | Not yet classified | Terminated | SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer... SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021". The TEE/8-3 MHz Transducer is designed for 2D, M Mode, color Doppler, pulse wave (PW) Doppler and contin | The TEE transesophageal transducer, when connected to a SonoSite M-Turbo Ultrasound System, may exhibit erratic operation of the Scanplane Orientation Indicator on the system display. The indicator may move erratically and not accurately represent the orientation of the TEE transducer array. | accessdata.fda.gov |
| November 2, 2007 | 49387 | Not yet classified | Terminated | Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultrasound system. The LAP Transducer label is labeled in part: "MicroMaxx LAP...Manufactured for SonoSite, Inc., Bothell, WA 98021". | Sterilization of the SonoSite LAP surgical Transducer with the Sterrad NX System may result in damage to the transducer. | accessdata.fda.gov |
| February 5, 2007 | 37452 | Not yet classified | Terminated | MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer | Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db. | accessdata.fda.gov |
| December 12, 2005 | 34250 | Not yet classified | Terminated | SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Manufactured for: SonoSite, Inc., Bothell, WA 98021 Each kit is packaged in a hermetically sealed clear plastic pouch with white backing. Product is labeled | 22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides. | accessdata.fda.gov |
| October 26, 2005 | 34808 | Not yet classified | Terminated | SonoCalc IMT 3.0, a windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS). This software generates a report with the patients intima media | When SonoCalc IMT 3.0 software is used with the SonoSite 180Plus ultrasound system, the software miscalculates the intima-media-thickness, a measurement of risk for cardiovascular or cerebrovascular events. Underestimates percentage of stenosis, false negative result. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Digital Image Communications, Radiological
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Image Processing, Radiological
- All makers of Biopsy Needle Guide Kit
Updated March 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.