SIEMENS INFINITY MODULAR MONITORS - With Scio
by Siemens Medical Solutions USA, Inc.
510(k) K031340
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK031340 | Date25 Nov 2003 | 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- Withdrawn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
- MHX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Siemens Infinity Modular Monitors SC 8000, SC 7000, and SC 9000XL with SCIO are physiological patient monitors designed for multi-parameter monitoring. These devices are classified as monitors for patient arrhythmia detection or alarms and are intended for continuous assessment of vital signs in clinical settings.
These monitors are supplied as reusable medical devices and are intended for use in hospital or clinical environments. They are not sterile and require proper maintenance and calibration. The devices are authorised under FDA 510(k) clearance with a classification of Class II (MHX). They may be integrated with the Siemens R50 Bedside Recorder via direct connection or the INFINITY Network for data recording and transmission.
Other devices from Siemens Medical Solutions USA, Inc.
Questions
AI-generated answers, 19 Sep 2026
Are these monitors intended for single-use or can they be reused in a clinical setting?
The Siemens Infinity Modular Monitors (SC 8000, SC 7000, and SC 9000XL with SCIO) are explicitly designed as reusable medical devices. Since they are not sterile and require proper maintenance and calibration, they are meant for repeated use in hospital or clinical environments, provided they are cleaned, serviced, and maintained according to manufacturer guidelines.
Can these monitors be integrated with other Siemens systems for data recording and transmission?
Yes, these monitors support integration with the Siemens R50 Bedside Recorder through a direct connection or via the INFINITY Network. This allows for seamless data recording and transmission, enhancing clinical workflows and enabling centralized monitoring capabilities.
Are these monitors sterile, and if not, how should they be handled before first use?
No, the Siemens Infinity Modular Monitors are not sterile. Since they are reusable, they must undergo proper cleaning, disinfection, and maintenance before each use. Follow the manufacturer’s instructions for sterilization (if applicable) and calibration to ensure safe and accurate operation in clinical settings.
What types of vital signs can these monitors continuously assess, and in which clinical environments are they typically used?
These monitors are multi-parameter physiological devices designed for continuous assessment of vital signs, including arrhythmia detection and alarms. They are intended for use in hospital or clinical environments where real-time patient monitoring is critical, such as ICUs, emergency rooms, and surgical units.
How do I determine which model (SC 8000, SC 7000, or SC 9000XL with SCIO) is best suited for my facility’s needs?
The Siemens Infinity Modular Monitors come in three models (SC 8000, SC 7000, and SC 9000XL with SCIO), each designed for multi-parameter monitoring with arrhythmia detection and alarms. While the exact specifications for each model are not detailed here, the choice typically depends on factors like display size, connectivity options, and integration needs with your facility’s existing systems. Consult Siemens’ technical documentation or a sales representative to match the model to your clinical workflow requirements.