MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214— 510(k) K090785

Clearance details

Applicant

Invivo Corp.

Product code

Code MWI

Device class

Class 2

Regulation

21 CFR 870.2300

Advisory panel

Cardiovascular

Date received

2009-03-23

Decision date

2009-12-15

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-2810-2020 — Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery 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-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-2244-2020 — Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring system or MRI gating solution. The Chest Pneumograph is indicated for use by healthcare professionals with the Wireless Sp02 (wSp02) Module or Toshiba KSB gating unit when bellows-derived respiration sensing is needed during MRI scans for gating.Class II·Terminated·Philips North America, LLC·20200413
• Z-0468-2013 — Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.Class II·Terminated·Invivo Corporation·20121015

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090785.