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Device (706 Ecg +5 more) - 705 Ecg

FDA 510(k)

Class II (US FDA 510(k))

510(k) K901504

by Ivy Biomedical Systems, Inc.

Identifiers

510(k) Number
K901504 FDA 510(k)
FDA Product Code
DQA FDA 510(k)
Models / Variants
706 Ecg FDA 510(k)
Pressure FDA 510(k)
Resp. FDA 510(k)
Sao2 FDA 510(k)
705 Ecg FDA 510(k)
Resp. FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2700 FDA 510(k)
Regulation Number
870.2700 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a cardiac gating monitor designed for synchronizing radiographic image acquisition. It integrates electrocardiogram (ECG), respiratory rate, blood pressure, and oxygen saturation (SaO₂) monitoring to ensure precise timing alignment with imaging modalities such as nuclear medicine, computed tomography (CT), magnetic resonance (MR), and single-photon emission computed tomography (SPECT).

The Models 706 and 705 are supplied as reusable medical devices intended for clinical use in radiology and imaging departments. They require FDA 510(k) clearance (K901504) and are classified under product code DQA. No specific sterility or MRI safety classifications are stated in the regulatory data.

Frequently asked questions

What types of imaging procedures can this device synchronize with, and why is this important for patient care?

The Models 706 and 705 are designed to synchronize radiographic image acquisition with cardiac gating for imaging modalities like nuclear medicine, computed tomography (CT), magnetic resonance (MR), and single-photon emission computed tomography (SPECT). This synchronization ensures precise timing alignment between the patient’s ECG, respiratory rate, blood pressure, and oxygen saturation (for Model 706) with the imaging process, reducing motion artifacts and improving image clarity for accurate diagnostics.

Are these devices single-use or reusable, and what does that mean for maintenance and cost?

The Models 706 and 705 are reusable medical devices, meaning they are built for repeated use in clinical settings like radiology and imaging departments. This design reduces single-use costs over time but requires proper cleaning, disinfection, and maintenance between patients to ensure reliability and safety. Reusability also aligns with sustainability goals by minimizing waste.

What key physiological parameters do these models monitor, and how does that differ between the 706 and 705?

Model 706 monitors ECG, respiratory rate, blood pressure, and oxygen saturation (SaO₂), while Model 705 focuses on ECG and respiratory rate only. The added parameters in the 706 provide comprehensive cardiac and respiratory synchronization for imaging, which can be critical for patients with cardiovascular or respiratory conditions where real-time monitoring of blood pressure and oxygen levels is beneficial.

How should these devices be stored when not in use, and are there any special considerations for their longevity?

While specific storage instructions aren’t detailed in the data, reusable medical devices like these typically require clean, dry, and protected storage to prevent damage or contamination. Since they lack explicit sterility or MRI safety classifications, they should be stored away from magnetic fields or sources of electromagnetic interference if used in MR environments. Proper maintenance, as outlined by the manufacturer, will ensure their longevity and performance.

What regulatory pathway was followed for FDA clearance, and how does that affect its use in clinical settings?

The Models 706 and 705 received FDA 510(k) clearance (K901504) through a traditional review process, determined to be *substantially equivalent* to a predicate device by the Cardiovascular (CV) advisory committee. This clearance confirms their safety and effectiveness for synchronizing radiographic imaging with cardiac/respiratory monitoring, allowing their use in radiology and imaging departments under standard clinical protocols. The classification under product code DQA (Diagnostic, Other) reflects their role in diagnostic imaging support.

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: Models 706 Ecg/Pressure/Resp./Sao2, 705 Ecg/Resp., Models 706 Ecg/Pressure/Resp./Sao2, 705 Ecg/Resp. - Beudamed, PDF K901504 - Models 706 Ecg/Pressure/Resp./Sao2, 705 Ecg/Resp., fda.innolitics.com, IVY BIOMEDICAL SYSTEMS, INC. FDA Filings - FDA.report

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) K901504 24 fields · synced Sep 18, 2026