Invivo Corporation
Invivo Corporation holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2021, with 19 FDA device recalls on record.
Top product codes for Invivo Corporation
FDA recalls by Invivo Corporation
10 most recent of 19- Z-0126-2021 — MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
- Z-1440-2020 — Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
- Z-0462-2019 — Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
- Z-3192-2018 — Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
- Z-1867-2018 — PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers.
- Z-1289-2018 — DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processing software package designed to provide a reliable means for analyzing MR datasets.
- Z-2115-2018 — Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves.
- Z-0263-2018 — Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
- Z-0082-2018 — Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status.
- Z-2688-2016 — Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Invivo Corporation
- K213766 — dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T
- K212227 — Philips MR Patient Care Portal
- K212175 — DynaCAD
- K193403 — UroNav System
- K192200 — DynaCAD
- K182561 — UroNav (Version 3.0)
- K162177 — dS FootAnkle I6CH 1.5T Coil
- K162001 — 1.5T and 3.0T 16 CH GE Shoulder Coils
- K152330 — Expression MR400 MRI Patient Monitoring System
- K153073 — UroNav (Version 2.0)
- K133030 — DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)
- K132359 — MRI PATIENT MONITORING SYSTEM
- K131382 — EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL
- K124061 — MRI PATIENT MONITORING SYSTEM (MODEL 865214)
- K122897 — SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645
- K122646 — DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T
- K121424 — EXPRESSION INFORMATION PORTAL
- K120122 — SENSE MSK S 8CH 1.5T
- K111673 — 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
- K103700 — ESSENTIAL MRI PATIENT MONITOR
- K103149 — 1.5T 16-CHANNEL HAND-WRIST COIL
- K093842 — 1.5T AND 3.0T GENERAL PURPOSE FLEX COILS
- K093284 — 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL
- K081262 — DC NEURO
- K062767 — CTL-63 AND CTL-128 SPINE ARRAY COILS
- K062144 — ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810
- K061675 — VISION VXC CENTRAL STATION, MODEL 4300
- K053462 — 3160 MRI PATIENT MONITORING SYSTEM
- K053017 — MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
Data sourced from openFDA. This site is unofficial and independent of the FDA.