FUJIFILM SonoSite,Inc.
Bothell, WA, US
FUJIFILM SONOSITE,INC. appears in FDA device records in Bothell, WA. FDA records list 48 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to FUJIFILM SonoSite,Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Sonosite,Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 48 510(k) clearances for FUJIFILM SonoSite,Inc. between 1998 and 2026. The busiest year on record is 2016, with 7. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 1 |
| 2005 | 3 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 2 |
| 2013 | 3 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 7 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 1 |
| 2023 | 1 |
| 2025 | 3 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260595 | Sonosite iLOOK Ultrasound System | IYN | Substantially Equivalent | |
| K253448 | Sonosite MT Ultrasound System | IYN | Substantially Equivalent | |
| K251106 | Sonosite LX and Sonosite PX Ultrasound Systems | IYN | Substantially Equivalent | |
| K251830 | Sonosite LX Ultrasound System | IYN | Substantially Equivalent | |
| K233597 | Sonosite LX Ultrasound System | IYN | Substantially Equivalent | |
| K213763 | Sonosite PX Ultrasound System | IYN | Substantially Equivalent | |
| K202160 | Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System | IYN | Substantially Equivalent | |
| K200964 | Sonosite PX Ultrasound System | IYN | Substantially Equivalent | |
| K190476 | FUJIFILM Sonosite Vevo MD Imaging System | IYN | Substantially Equivalent | |
| K183235 | SonoSite SII Ultrasound System | IYN | Substantially Equivalent | |
| K180704 | SonoSite iViz Ultrasound System | IYN | Substantially Equivalent | |
| K171437 | SonoSite X-Porte Ultrasound System | IYN | Substantially Equivalent | |
| K162288 | SonoSite iViz Ultrasound System | IYN | Substantially Equivalent | |
| K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | IYN | Substantially Equivalent | |
| K161119 | SonoSite iViz Ultrasound System | IYN | Substantially Equivalent | |
| K160674 | Fujifilm Sonosite Vevo MD Imaging System | IYN | Substantially Equivalent | |
| K160734 | SonoSite SII Ultrasound System | IYN | Substantially Equivalent | |
| K160406 | FUJIFILM FC1 Ultrasound System | IYN | Substantially Equivalent | |
| K153626 | SonoSite Edge II Ultrasound System | IYN | Substantially Equivalent | |
| K152983 | FUJIFILM SonoSite iViz Ultrasound System | IYN | Substantially Equivalent | |
| K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | IYN | Substantially Equivalent | |
| K142017 | X-PORTE ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K133454 | SONOSITE EDGE ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K133134 | X-PORTE ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K130173 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K113156 | SONOSITE EDGE ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K110645 | BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR | DSB | Substantially Equivalent | |
| K102390 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K093510 | LUMENVU CATHETER GUIDANCE SYSTEM | OMF | Substantially Equivalent | |
| K101757 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM | ITX | Substantially Equivalent | |
| K092058 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K082098 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K071134 | SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K053069 | SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | IYN | Substantially Equivalent | |
| K052109 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) | IYN | Substantially Equivalent | |
| K043559 | SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | IYN | Substantially Equivalent | |
| K043452 | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K033367 | TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464 | IYN | Substantially Equivalent | |
| K030949 | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K030064 | ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY | ITX | Substantially Equivalent | |
| K023957 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES) | IYN | Substantially Equivalent | |
| K021628 | SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES) | IYN | Substantially Equivalent | |
| K014116 | HAND-CARRIED ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K010374 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K003399 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K994096 | SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM | IYN | Substantially Equivalent | |
| K990806 | C1 ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K981505 | COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3032367 | 3002087856 | FUJIFILM SONOSITE,INC. | 21919 30th Dr SE, BOTHELL, WA 98021 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QIHAutomated Radiological Image Processing Software
- OIJBiopsy Needle Guide Kit
- OMFPercutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
- DSBPlethysmograph, Impedance
- LMDSystem, Digital Image Communications, Radiological
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0027-2014 | 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 Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler. | FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended. | Class II | Terminated | |
| Z-0057-2012 | 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 analysis of the human body. | 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. | Terminated | ||
| Z-0478-2011 | The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The software is used with the SonoSite NanoMaxx ultrasound system. | Software ARM version 60.80.101.025 (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. | Terminated | ||
| Z-2116-2010 | 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 and the docking assembly is plugged into a wall circuit. It provides a docking and charging station for the V and H Universal Stands. The product marketing brochure labeled in part: "SonoSite Ltd...21919 30th Drive SE... Bothell, WA 98021, USA". | PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment. | Terminated | ||
| Z-2191-2010 | 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 continuous wave (CW) Doppler by applying ultrasound energy through the esophagus or stomach of the patient into the heart. The TEE transducer is intended to be used on adults only. Backscattered ultrasound energy from the patient's heart is used to form images of the heart to detect abnormalities in structure or motion, to evaluate the velocity of blood flowing within the heart, and to obtain a color depiction of the velocities of blood flowing in the heart. | 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. | Terminated | ||
| Z-2655-2010 | SLT transducer is used on the SonoSite MicroMaxx ultrasound system. The SLT Transducer label is labeled in part: " MicroMaxx SLT...Manufactured for SonoSite, Inc., Bothell, WA 98021". | Sterilization of the SonoSite SLT ultrasound surgical transducer with the Sterrad NX System may result in damage to the transducer. | Terminated | ||
| Z-2654-2010 | 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. | Terminated | ||
| Z-0661-2007 | MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer | Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db. | Terminated | ||
| Z-0407-06 | 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 as Sterile. 24 pouches are packaged in a white cardboard box and labeled as SonoSite L25 Needle Guide Kit, 21 GAUGE REF# P04053-01, Quantity: 24, CONTENTS STERILE IF PACKAGE IS INTACT. Mfg for: Sonosite, Inc. 888/482-9449*425/951-1200, Bothell, WA 98021 USA. www.sonosite.com | 22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides. | Terminated | ||
| Z-0713-06 | 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 thickness (IMT) based on average thickness of the carotid artery. | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain