Expression MR200 MRI Patient Monitoring System, Expression IP5 Information Portal
FDA 510(k) K131382 · Invivo Corporation
510(k) numberK131382
Submission
- Device name
- Expression MR200 MRI Patient Monitoring System, Expression IP5 Information Portal
- Applicant
- Invivo Corporation
Orlando, FL, US - Received
- May 14, 2013
- Decision date
- July 15, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code MWI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260438 | Vital Signs Monitor (CLEO2)MWI · Traditional | Infinium Medical, Inc. | 08/14/2026SE |
| K253417 | Masimo Root Monitoring SystemMWI · Traditional | Masimo Corporation | 08/12/2026SE |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)MWI · Traditional | Midmark Corporation | 06/12/2026SE |
| K253436 | c-med0 alphaMWI · Traditional | Cosinuss GmbH | 04/30/2026SE |
| K250135 | WAVE Clinical Platform (2.0.000)MWI · Traditional | Baxter Healthcare Corp/ Excel Medical | 01/16/2026SE |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)MWI · Traditional | Fysicon BV | 08/27/2025SE |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional | Empatica S.r.l. | 06/06/2025SE |
| K241958 | WARD-CSS (v1.2.x)MWI · Traditional | Ward 24/7 Aps | 02/14/2025SE |
| K243146 | iCare APPMWI · Traditional | Ihealth Labs, Inc. | 02/03/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | Welch Allyn, Inc. | 12/20/2024SE |
More from Welch Allyn, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and…MOS · Traditional | 12/23/2021SE |
| K212227 | Philips MR Patient Care PortalMWI · Traditional | 09/30/2021SE |
| K212175 | DynaCADLLZ · Abbreviated | 08/02/2021SE |
| K193403 | UroNav SystemLLZ · Traditional | 12/27/2019SE |
| K192200 | DynaCADLLZ · Traditional | 10/09/2019SE |
| K182561 | UroNav (Version 3.0)LLZ · Traditional | 10/19/2018SE |
| K162177 | dS FootAnkle I6CH 1.5T CoilMOS · Traditional | 09/14/2016SE |
| K162001 | 1.5T and 3.0T 16 CH GE Shoulder CoilsMOS · Traditional | 08/31/2016SE |
| K152330 | Expression MR400 MRI Patient Monitoring SystemMWI · Special | 12/23/2015SE |
| K153073 | UroNav (Version 2.0)LLZ · Traditional | 11/16/2015SE |
Questions and answers
When was Expression MR200 MRI Patient Monitoring System, Expression IP5 Information Portal cleared by the FDA?
Expression MR200 MRI Patient Monitoring System, Expression IP5 Information Portal (K131382) received a 510(k) decision of Substantially Equivalent on July 15, 2013, 62 days after the submission was received.
What is the product code of K131382?
The FDA product code is MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.2300.