Company ยท US
Sonosite,Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2011. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 22 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 |
| ITX | Transducer, Ultrasonic, Diagnostic | 3 |
| DSB | Plethysmograph, Impedance | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
| OMF | Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 15, 2011 | K113156 | SONOSITE EDGE ULTRASOUND SYSTEM Sonosite,Inc. | IYO |
| Jun 3, 2011 | K110645 | BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR Sonosite,Inc. | DSB |
| Nov 19, 2010 | K102390 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM Sonosite,Inc. | IYN |
| Aug 23, 2010 | K093510 | LUMENVU CATHETER GUIDANCE SYSTEM Sonosite,Inc. | OMF |
| Aug 12, 2010 | K101757 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM Sonosite,Inc. | ITX |
| Oct 2, 2009 | K092058 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM Sonosite,Inc. | IYN |
| Aug 25, 2008 | K082098 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM Sonosite,Inc. | IYN |
| May 8, 2007 | K071134 | SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM Sonosite,Inc. | IYO |
| Nov 16, 2005 | K053069 | SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) Sonosite,Inc. | IYN |
| Aug 11, 2005 | K052109 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) Sonosite,Inc. | IYN |
| Jan 12, 2005 | K043559 | SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) Sonosite,Inc. | IYN |
| Dec 21, 2004 | K043452 | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM Sonosite,Inc. | IYN |
| Nov 5, 2003 | K033367 | TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464 Sonosite,Inc. | IYN |
| Apr 7, 2003 | K030949 | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM Sonosite,Inc. | IYN |
| Jan 22, 2003 | K030064 | ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY Sonosite,Inc. | ITX |
| Dec 12, 2002 | K023957 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES) Sonosite,Inc. | IYN |
| May 31, 2002 | K021628 | SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES) Sonosite,Inc. | IYN |
| Dec 20, 2001 | K014116 | HAND-CARRIED ULTRASOUND SYSTEM Sonosite,Inc. | IYN |
| Feb 21, 2001 | K010374 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM Sonosite,Inc. | IYN |
| Nov 16, 2000 | K003399 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM Sonosite,Inc. | IYN |
| Dec 20, 1999 | K994096 | SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM Sonosite,Inc. | IYN |
| Mar 26, 1999 | K990806 | C1 ULTRASOUND SYSTEM Sonosite,Inc. | IYN |
| May 8, 1998 | K981505 | COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM Sonosite,Inc. | IYO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2013 | SonoSite, Inc. 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 So Terminated |
IYO | K113156 K130173 |
| Oct 18, 2011 | Sonosite, Inc. 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 im Terminated |
IYN | K043559 K053069 +2 |
| Nov 26, 2010 | Sonosite, Inc. 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. Terminated |
IYN | K092058 |
| Oct 1, 2010 | Sonosite, Inc. 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". Terminated |
IYN | K043559 |
| Oct 1, 2010 | Sonosite, Inc. 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., Terminated |
IYN | K043559 |
| Aug 9, 2010 | Sonosite, Inc. 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 (P Terminated |
IYO | K071134 |
| Aug 2, 2010 | Sonosite, Inc. 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 Terminated |
IYN | K053069 K082098 +1 |
| Mar 29, 2007 | Sonosite, Inc. MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer Terminated |
IYN | K043559 K053069 |
| Apr 6, 2006 | Sonosite, Inc. 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 p Terminated |
LLZ | K030223 |
| Jan 19, 2006 | Sonosite, Inc. 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 back Terminated |
ITX | K030064 |