FDA 510(k) · Sotera
K180472: ViSi Mobile Monitoring System (Sotera Wireless, Inc.)
Sotera Wireless, Inc. received FDA 510(k) K180472 for ViSi Mobile Monitoring System, with a decision date of Jun 19, 2018 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K180472 |
|---|---|
| Pathway | 510(k) |
| Applicant | Sotera Wireless, Inc. |
| Device name | ViSi Mobile Monitoring System |
| Product code | MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Regulation (21 CFR) | 870.1025 |
| Device class | Class 2 |
| Date received | Feb 22, 2018 |
| Decision date | Jun 19, 2018 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The ViSI Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), skin temperature (TEMP), posture tracking and alarms, and basic arrhythmia (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Fibrillation) analysis and alarm in hospital-based facilities including general medical-surgical floors, intermediate care floors, and emergency departments. Continuous non-invasive blood pressure (cNIBP) measurements have not been evaluated on patients during ambulation. The basic arrhythmia analysis feature is intended for use on patients 18 years of age and older; it has not been evaluated on pediatric patients. The arrhythmia analysis feature is intended for use by healthcare professionals trained in the identification and treatment of arrhythmia events. Automated arrhythmia analysis is an adjunct to clinical assessment; clinician review of the analysis should precede any therapeutic intervention. The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication. The VisI Mobile Insight is an optional secondary notification system that communicates alarms directly to an assigned caregiver. It is intended to supplement the primary alarming devices which originate in the ViSI Mobile patient-worn device.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K180472
- K230626 Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01); Portrait Mobile Patient Monitor (Portrait HUB01), Portrait Sensor Battery (Portrait SBT01), Portrait Bedside Charger (Portrait BCH01); Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait SpO2 Attachment Accessory Band (Portrait AAB01), Portrait (GE Medical Systems Information Technologies, Aug 11, 2023, MWI)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code MHX is "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", class 2, 21 CFR 870.1025.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.