Universal Physiological Measurement Module
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091985 FDA 510(k)
- FDA Product Code
- DRT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Universal Physiological Measurement Module is a Cardiac Monitor (including cardiotachometer and rate alarm) designed for precise physiological signal acquisition. It measures and synchronizes cardiac activity to enable accurate timing of radiographic image capture across various imaging modalities, including nuclear medicine, computed tomography, and magnetic resonance imaging.
This device is intended for use in clinical settings where synchronized imaging is required, such as radiology departments and nuclear medicine facilities. Supplied as a reusable medical instrument, it is not sterile and must be cleaned and maintained according to manufacturer guidelines. The module adheres to FDA 510(k) clearance under the Cardiovascular advisory committee and is classified as a Class II device under regulation 21 CFR 870.2300. No MRI safety classification or single-use designation is specified.
Frequently asked questions
What clinical settings is this device designed for and how does it integrate with imaging modalities?
The Universal Physiological Measurement Module is specifically designed for clinical settings requiring synchronized imaging, such as radiology departments and nuclear medicine facilities. It measures and synchronizes cardiac activity to enable precise timing of radiographic image capture across modalities like nuclear medicine, computed tomography (CT), and magnetic resonance imaging (MRI). This ensures that images are captured in alignment with the patient’s cardiac cycle, improving diagnostic accuracy for procedures dependent on synchronized physiological data.
Is this device intended for single-use or reusable applications, and what maintenance is required?
The Universal Physiological Measurement Module is supplied as a reusable medical instrument and is not sterile. It must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper functionality and hygiene. Since it is not designated for single-use, regular upkeep is essential for reliable performance in clinical environments.
What regulatory pathway was followed for FDA clearance, and what classification does this device hold?
The device received FDA clearance through a 510(k) submission, classified as Substantially Equivalent (SE) under the Cardiovascular (CV) Advisory Committee. It is categorized as a Class II device under 21 CFR 870.2300, which governs cardiac monitors (including cardiotachometers and rate alarms). The clearance was granted via a Special 510(k) process, reflecting its compliance with regulatory standards for synchronized physiological monitoring.
Does this device have any specific MRI safety considerations, and if not, how should it be used in MRI environments?
The provided data does not specify an MRI safety classification for the Universal Physiological Measurement Module. If used in MRI environments, it should be handled with caution, and the manufacturer’s instructions must be followed to avoid interference with MRI operations. Users should confirm compatibility with their specific MRI system and consult Ivy Biomedical Systems for guidance on safe integration.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Universal Physiological Measurement Module 510 (k) FDA Premarket ..., UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE (K091985) — FDA 510 (k ..., Ivy Biomedical Systems, Inc. Welcome
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091985 | Class II | Active |
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Manufacturer
- Manufacturer
- Ivy Biomedical Systems, Inc.
Sources (1)
- FDA 510(k) K091985 24 fields · synced Sep 18, 2026