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PHYSIOLOGICAL MONITOR - 101

FDA 510(k)

Class II (US FDA 510(k))

510(k) K854840

by Ivy Biomedical Systems, Inc.

Identifiers

510(k) Number
K854840 FDA 510(k)
FDA Product Code
DPS FDA 510(k)
Models / Variants
101 FDA 510(k)
301 FDA 510(k)
201 FDA 510(k)
202 FDA 510(k)
303a FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Physiological Monitor designed for real-time cardiac gating, enabling precise synchronization of radiographic imaging modalities. It detects and processes R-wave signals from electrocardiograms (ECGs) to coordinate image acquisition with cardiac cycles, ensuring accurate diagnostic imaging in nuclear medicine, computed tomography (CT), magnetic resonance (MR), positron emission tomography (PET), and single-photon emission computed tomography (SPECT).

The monitor is supplied as a reusable medical device intended for clinical use in radiology and imaging departments. It requires FDA 510(k) clearance (K854840) and is classified under the Product Code DPS. No sterility or single-use specifications are indicated; it is intended for repeated use in controlled environments where ECG synchronization is required for imaging procedures.

Frequently asked questions

What specific imaging modalities does this physiological monitor synchronize with cardiac cycles for precise diagnostic imaging?

This monitor is designed for real-time cardiac gating to synchronize radiographic imaging in nuclear medicine, computed tomography (CT), magnetic resonance (MR), positron emission tomography (PET), and single-photon emission computed tomography (SPECT). By detecting and processing R-wave signals from ECGs, it ensures images are acquired in alignment with the cardiac cycle, improving diagnostic accuracy for these modalities.

Is this device intended for single-use or repeated use in clinical settings, and what are the implications for maintenance?

The device is explicitly intended for repeated use in controlled clinical environments like radiology and imaging departments. Since it is reusable, proper cleaning, calibration, and maintenance protocols must be followed to ensure reliable ECG signal detection and synchronization across multiple procedures. No sterility requirements are specified, but standard infection control practices for reusable medical devices should be adhered to.

What are the key differences between the models 101, 301, 201, 202, and 303A of this physiological monitor?

The provided data does not specify technical or functional distinctions between the models (101, 301, 201, 202, 303A). However, they are all classified under the same FDA 510(k) clearance (K854840) and product code (DPS), suggesting they share core functionality for cardiac gating in imaging. Differences—such as features, connectivity, or compatibility—would require consulting the manufacturer’s technical documentation or contacting Ivy Biomedical Systems directly for precise model comparisons.

How is this monitor regulated, and what does the FDA’s 510(k) clearance (K854840) imply about its safety and equivalence?

This monitor holds FDA 510(k) clearance (K854840) under the Product Code DPS, with a decision labeled as *Substantially Equivalent* to a predicate device. This clearance implies the manufacturer has demonstrated that the device’s design and performance meet regulatory standards for safety and effectiveness, with no significant changes to established risks. The clearance was granted by the Cardiovascular (CV) Advisory Committee in 1986, confirming its compliance with FDA requirements for physiological monitors used in cardiac-gated imaging.

Where is this device manufactured, and who should I contact for technical support or inquiries?

The manufacturer, Ivy Biomedical Systems, Inc., is based at 11 Business Park Dr., Branford, CT 06405. For technical support, product inquiries, or maintenance questions, you should contact Richard A. Mentelos, the listed contact at the manufacturer’s address. Always verify current contact details through Ivy Biomedical’s official channels, as this information may have evolved since the 1986 clearance.

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: Physiological Monitor, Models 101,301,201,202,303a, IVY BIOMEDICAL SYSTEMS 101R SERVICE MANUAL Pdf Download, Ivy biomedical systems 101NR Manuals | ManualsLib, Ivy Operator Manuals - Ivy Biomedical Systems

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ivy Biomedical Systems, Inc.

Sources (1)

  • FDA 510(k) K854840 24 fields · synced Sep 18, 2026