Invivo Corporation
FDA Regulatory Profile
Invivo Corporation appears in FDA public data with 19 recalls, 29 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0126-2021, Class III) was initiated on September 14, 2020. Its most recent 510(k) clearance was granted on December 23, 2021.
Summary
- Total Recalls
- 19
- 510(k) Clearances
- 29
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0126-2021 | Class III | MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to p | September 14, 2020 |
| Z-1440-2020 | Class II | Monitor for the Functional Imaging System for Magnetic Resonance Imaging System | February 6, 2020 |
| Z-0462-2019 | Class II | Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 | September 24, 2018 |
| Z-3192-2018 | Class II | Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388 | August 3, 2018 |
| Z-1867-2018 | Class II | PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564 | March 14, 2018 |
| Z-1289-2018 | Class II | DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The | January 24, 2018 |
| Z-2115-2018 | Class II | Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to | November 20, 2017 |
| Z-0263-2018 | Class II | Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and | August 18, 2017 |
| Z-0082-2018 | Class II | Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to f | August 11, 2017 |
| Z-2688-2016 | Class II | Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1 | May 6, 2016 |
| Z-2760-2016 | Class II | The system provides the ability to transmit patient data files for storage, viewing and analysis at | October 19, 2015 |
| Z-0958-2015 | Class II | Philips Expression MR200 MRI Patient Monitoring System. | October 22, 2014 |
| Z-2867-2016 | Class II | Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a seco | September 14, 2014 |
| Z-0001-2015 | Class II | Philips Expression MR200 MRI Patient Monitoring System Model 866120 | September 8, 2014 |
| Z-0069-2015 | Class II | Philips Expression MR200 MRI Patient Monitoring System | September 5, 2014 |
| Z-2270-2014 | Class II | Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and devic | June 30, 2014 |
| Z-0983-2014 | Class II | Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary d | December 4, 2013 |
| Z-1096-2014 | Class II | Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Informati | October 3, 2013 |
| Z-0468-2013 | Class II | Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitorin | October 15, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small | December 23, 2021 |
| K212227 | Philips MR Patient Care Portal | September 30, 2021 |
| K212175 | DynaCAD | August 2, 2021 |
| K193403 | UroNav System | December 27, 2019 |
| K192200 | DynaCAD | October 9, 2019 |
| K182561 | UroNav (Version 3.0) | October 19, 2018 |
| K162177 | dS FootAnkle I6CH 1.5T Coil | September 14, 2016 |
| K162001 | 1.5T and 3.0T 16 CH GE Shoulder Coils | August 31, 2016 |
| K152330 | Expression MR400 MRI Patient Monitoring System | December 23, 2015 |
| K153073 | UroNav (Version 2.0) | November 16, 2015 |
| K133030 | DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) | January 22, 2014 |
| K132359 | MRI PATIENT MONITORING SYSTEM | August 30, 2013 |
| K131382 | EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL | July 15, 2013 |
| K124061 | MRI PATIENT MONITORING SYSTEM (MODEL 865214) | February 22, 2013 |
| K122897 | SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 | December 21, 2012 |
| K122646 | DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T | November 2, 2012 |
| K121424 | EXPRESSION INFORMATION PORTAL | June 13, 2012 |
| K120122 | SENSE MSK S 8CH 1.5T | February 10, 2012 |
| K111673 | 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL | December 23, 2011 |
| K103700 | ESSENTIAL MRI PATIENT MONITOR | March 15, 2011 |