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Patient Monitor Model 703

FDA 510(k)

Class II (US FDA 510(k))

510(k) K884662

by Ivy Biomedical Systems, Inc.

Identifiers

510(k) Number
K884662 FDA 510(k)
FDA Product Code
DPS 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)

The Patient Monitor Model 703 is a cardiac gating monitor designed for synchronizing radiographic image acquisition. It is classified as a patient monitor under the FDA’s Product Code DPS and is intended for use in imaging modalities such as nuclear medicine, computed tomography, and magnetic resonance imaging.

This device is supplied as a reusable Class II medical device and has received FDA 510(k) clearance under K884662. It was originally submitted to the Cardiovascular (CV) Advisory Committee in 1988 and granted Substantially Equivalent (SE) status in February 1989. No third-party review was required for this authorization.

Frequently asked questions

What is the primary purpose of the Patient Monitor Model 703, and in which imaging modalities can it be used?

The Patient Monitor Model 703 is designed specifically for cardiac gating, which synchronizes radiographic image acquisition with the patient’s heartbeat. This ensures clearer, more precise imaging by aligning scans with the cardiac cycle. It is approved for use in nuclear medicine, computed tomography (CT), and magnetic resonance imaging (MRI) to improve diagnostic accuracy in these modalities.

Is the Patient Monitor Model 703 intended for single-use or reusable applications, and how does this affect its maintenance?

The Patient Monitor Model 703 is classified as a reusable Class II medical device, meaning it is not disposable. This allows for repeated use across multiple patients, but it requires proper cleaning, disinfection, and maintenance procedures as outlined in Ivy Biomedical Systems’ instructions to ensure safety, functionality, and compliance with regulatory standards.

How was the FDA clearance for this device determined, and what role did the Cardiovascular Advisory Committee play in the approval process?

The Patient Monitor Model 703 received Substantially Equivalent (SE) status under FDA’s 510(k) clearance process (K884662). In 1988, Ivy Biomedical Systems submitted the device to the Cardiovascular (CV) Advisory Committee for review, which granted SE status in February 1989. This means the device was deemed comparable to a legally marketed predicate device, and no third-party review was required for final clearance.

What regulatory product code does the Patient Monitor Model 703 fall under, and how does this classification impact its use?

The device is classified under FDA Product Code DPS, which categorizes it as a patient monitor. This classification ensures it meets regulatory standards for devices that monitor physiological parameters (in this case, cardiac signals) to assist in imaging synchronization. The DPS code helps guide its intended use in clinical settings where precise timing with imaging modalities is critical.

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: K884662 FDA 510 (k) - PATIENT MONITOR MODEL 703, PATIENT MONITOR MODEL 703 (K884662) — FDA 510(k) | Innolitics, PDF K884662 PATIENT MONITOR MODEL 703 - 510kdatabase.net, Ivy Biomedical Monitor 703 - allmed.wiki

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) K884662 24 fields · synced Sep 18, 2026