# K063840: Xper Information Management/Physiomonitoring 5 System and/or Vascular 5, Patient Care Console and Central Station

- Pathway: 510(k) (Traditional)
- Applicant: Witt Biomedical Corp
- Decided: Feb 6, 2007 after 42 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033030 (2004). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033030: Calysto Series IV Patient Care Monitors and Central Station and Ecg Management System, Witt Biomedical Corp (2004) Summary page 1.

## Most influential descendants
- K101571: Xper Information Management and Flex Cardio Physiomonitoring Systems (2010), 5 descendants of its own
- K131497: Mckesson Cardiology Hemo (2013), 3 descendants of its own
- K170032: QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP (2017), 1 descendant of its own
- K241766: QMAPP®  (Hemo, Hemo Lite, PCM, GO, Hybrid) (2025), 0 descendants of its own
- K230881: Change Healthcare Cardiology Hemodynamics™ (2023), 0 descendants of its own

## Indications for use
Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station is intended for complete physiologic/hemodynamic monitoring, clinical data acquisition, medical image/data processing, and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. Xper Information ManagementlPhysiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device. Use of Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required. The Xper Information Management Central Station and Patient Care Consoles are intended for complete physiologic monitoring, clinical data acquisition, medical image processing and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses. Use of Xper Information Management Central Station and Patient Care Console is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required. The Xper Information Management ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. The Xper ECG Management system does not provide interpretive fUnctions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. The Xper ECG Management system provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

Source page: https://510kreport.com/device/K063840
Methodology: https://510kreport.com/methodology