EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL— 510(k) K131382

Clearance details

Applicant

Invivo Corporation

Product code

Code MWI

Device class

Class 2

Regulation

21 CFR 870.2300

Advisory panel

Cardiovascular

Date received

2013-05-14

Decision date

2013-07-15

Decision

Substantially Equivalent

Clearance type

Special

Location

Orlando, FL, US

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• K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

• 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 3.0T2021-12-23
• K212227 — Philips MR Patient Care Portal2021-09-30
• K212175 — DynaCAD2021-08-02
• K193403 — UroNav System2019-12-27
• K192200 — DynaCAD2019-10-09

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-2811-2020 — Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.Class II·Terminated·Philips North America, LLC·20200618
• Z-2812-2020 — Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.Class II·Terminated·Philips North America, LLC·20200618
• Z-0958-2015 — Philips Expression MR200 MRI Patient Monitoring System.Class II·Terminated·Invivo Corporation·20141022
• Z-0001-2015 — Philips Expression MR200 MRI Patient Monitoring System Model 866120Class II·Terminated·Invivo Corporation·20140908
• Z-0069-2015 — Philips Expression MR200 MRI Patient Monitoring SystemClass II·Terminated·Invivo Corporation·20140905

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131382.