MRI PATIENT MONITORING SYSTEM (MODEL 865214)— 510(k) K124061

Clearance details

Applicant

Invivo Corporation

Product code

Code MWI

Device class

Class 2

Regulation

21 CFR 870.2300

Advisory panel

Cardiovascular

Date received

2012-12-31

Decision date

2013-02-22

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-2266-2015 — Invivo Expression MRI Patient Monitoring System.Class II·Terminated·Philips Electronics North America Corporation·20150617

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K124061.