CSI Model 5K Managed Health System Kiosk
by Computerized Screening, Inc.
510(k) K093389
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK093389 | Date17 Nov 2009 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The CSI Model 5K Managed Health System Kiosk is a cardiovascular screening device designed to measure blood pressure, pulse, and weight. It is classified under the FDA product code DXN and is intended for public use in non-clinical settings. The system provides automated readings and data collection for these vital signs without requiring clinical interpretation.
This kiosk is supplied as a standalone unit for use in community health settings, such as clinics, wellness centers, or public health programs. It is not intended for single-use and is designed for repeated use in managed health environments. The device has received FDA 510(k) clearance under the traditional review pathway, with a decision date of November 17, 2009, and is regulated under the cardiovascular specialty classification.
Other devices from Computerized Screening, Inc.
Questions
AI-generated answers, 1 Oct 2026
What vital signs does the CSI Model 5K Kiosk measure?
The CSI Model 5K Kiosk measures blood pressure, pulse, and weight. These automated readings are designed for public use in non-clinical settings like community health programs, clinics, or wellness centers, where users can obtain their vital signs without clinical interpretation.
Is the CSI Model 5K Kiosk intended for single-use or repeated use?
The CSI Model 5K Kiosk is not intended for single-use. It is designed for repeated use in managed health environments, such as public health programs or wellness centers, where multiple individuals can utilize the device over time.
What type of regulatory clearance does the CSI Model 5K Kiosk have?
The CSI Model 5K Kiosk has received FDA 510(k) clearance under the traditional review pathway, with a decision date of November 17, 2009. It is classified under FDA product code DXN and falls under the cardiovascular specialty classification.
How is the CSI Model 5K Kiosk supplied, and where can it be used?
The CSI Model 5K Kiosk is supplied as a standalone unit, meaning it is not part of a larger system or kit. It is intended for use in non-clinical settings such as community health clinics, wellness centers, or public health programs where automated vital sign screening is needed.
What distinguishes the CSI Model 5K Kiosk from other cardiovascular screening devices?
The CSI Model 5K Kiosk is specifically designed for public, non-clinical use, providing automated readings for blood pressure, pulse, and weight without requiring clinical interpretation. Unlike some devices, it is built for repeated use in managed health environments, making it ideal for high-traffic settings like community health programs.