EXPRESSION INFORMATION PORTAL— 510(k) K121424

Clearance details

Applicant

Invivo Corporation

Product code

Code MWI

Device class

Class 2

Regulation

21 CFR 870.2300

Advisory panel

Cardiovascular

Date received

2012-05-14

Decision date

2012-06-13

Decision

Substantially Equivalent

Clearance type

Special

Location

Orlando, FL, US

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Death

16

Malfunction

963

Total

979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2867-2016 — Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.Class II·Terminated·Invivo Corporation·20140914
• Z-2270-2014 — Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.Class II·Terminated·Invivo Corporation·20140630
• Z-0983-2014 — Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs the measured patient data to a hospital information system (HIS). The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.Class II·Terminated·Invivo Corporation·20131204
• Z-1096-2014 — Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professional to remotely monitor the vital signs of patients undergoing MRI procedures. Available monitoring from the IP5 can include ECG, SpO2, non-invasive and invasive blood pressure, CO2, respiration, anesthetic agents, gases, and temperature parameters.Class II·Terminated·Invivo Corporation·20131003

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121424.