Horizon Perinatal Care Surveillance and Archival System Model Verson 4.0
by Mckesson Information Solutions, LLC
510(k) K102263
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102263 | Date5 May 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Horizon Perinatal Care Surveillance and Archival Model Verson 4.0
- 510(k) Number
- FDA Product Code
- HGM
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.2740
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Horizon Perinatal Care Surveillance and Archival System Model Verson 4.0 is a Monitoring System, Perinatal designed for centralised fetal and obstetrical patient surveillance. It enables simultaneous monitoring of multiple physiological parameters in perinatal patients, facilitating real-time correlation of clinical observations to support maternal and fetal care decisions.
This system is intended for use in obstetric settings and is supplied as a software-based solution. It has received FDA 510(k) clearance under the classification of Class II medical devices (regulation number 884.2740). The system is not described as single-use or reusable, nor are specific sterility or MRI safety details provided in the regulatory data. Storage and handling instructions are not specified in the available documentation.
Questions
AI-generated answers, 1 Oct 2026
What is the Horizon Perinatal Care Surveillance and Archival Model Verson 4.0 used for?
This system is designed for centralized fetal and obstetrical patient surveillance in obstetric settings. It enables simultaneous monitoring of multiple physiological parameters, allowing clinicians to correlate real-time clinical observations and support informed maternal and fetal care decisions. The software-based solution is intended to enhance decision-making by providing comprehensive data archival and analysis capabilities.
How is the Horizon Perinatal Care Surveillance and Archival Model Verson 4.0 supplied?
The system is supplied exclusively as a software-based solution. It does not include physical hardware components beyond those required for standard IT infrastructure, such as servers, monitors, and network connectivity. The software integrates with existing monitoring equipment to provide centralized surveillance and archival functions.
Is the Horizon Perinatal Care Surveillance and Archival Model Verson 4.0 single-use or reusable?
The regulatory data does not specify whether the software itself is single-use or reusable. However, as a software-based solution, it is typically installed on hospital or clinical network systems and remains functional for ongoing use until updated or replaced. The associated hardware components (e.g., monitors, servers) would follow standard IT asset management practices for reuse or disposal.
Does the Horizon Perinatal Care Surveillance and Archival Model Verson 4.0 require sterility or MRI safety considerations?
The regulatory documentation does not provide details on sterility requirements or MRI safety for this software-based system. Since it is a software solution, sterility is not applicable. MRI safety considerations would only pertain to any connected hardware devices, which are not detailed in the provided data.
What regulatory approval does the Horizon Perinatal Care Surveillance and Archival Model Verson 4.0 hold?
The system has received FDA 510(k) clearance under the classification of Class II medical devices, specifically under regulation number 884.2740. This clearance indicates that the device is deemed substantially equivalent to a predicate device already on the market, meeting the necessary safety and performance standards for obstetrics/gynecology applications.