Identifiers
- 510(k) Number
- K904606 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 Model 405 is a Cardiac Gating Monitor (Device Product Category DPS), designed to synchronize radiographic image acquisition with cardiac cycles. It provides precise timing signals for imaging modalities such as nuclear medicine, computed tomography (CT), magnetic resonance (MR), positron emission tomography (PET), and single photon emission computed tomography (SPECT).
This device is intended for use in clinical settings where synchronized cardiac imaging is required, ensuring accurate alignment of imaging data with the patient’s heartbeat. Supplied as a reusable medical instrument, it operates in environments compatible with MRI safety standards. Authorized under FDA 510(k) clearance (K904606), the Model 405 was classified as substantially equivalent to predicate devices in the Cardiovascular advisory committee category.
Frequently asked questions
What types of medical imaging systems can the Model 405 synchronize with, and why is this important for cardiac imaging?
The Model 405 is designed to synchronize imaging with cardiac cycles for modalities like nuclear medicine, CT, MR, PET, and SPECT. This synchronization ensures precise alignment of imaging data with the heartbeat, improving diagnostic accuracy by reducing motion artifacts and capturing clearer images of the heart’s structure and function.
Is the Model 405 intended for single-use or reusable applications, and what does this mean for maintenance and cost?
The Model 405 is supplied as a reusable medical instrument, meaning it is built for repeated use in clinical settings. This design reduces per-procedure costs and allows for proper maintenance and sterilization protocols to be applied, ensuring long-term reliability and compliance with infection control standards.
Can the Model 405 be used in MRI environments, and what safety considerations should be taken into account?
Yes, the Model 405 is designed to operate in MRI-compatible environments. Since it is intended for use in settings where MRI safety standards apply, it must be handled according to those guidelines—such as avoiding ferromagnetic materials and ensuring electromagnetic interference does not compromise imaging quality or patient safety.
What does the FDA 510(k) clearance (K904606) for the Model 405 mean for healthcare providers?
The FDA 510(k) clearance indicates that the Model 405 has been determined to be substantially equivalent to a legally marketed predicate device in the Cardiovascular advisory committee category. This means it meets FDA safety and effectiveness requirements for its intended use in synchronizing cardiac imaging, providing assurance to healthcare providers that the device adheres to regulatory standards for clinical application.
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: MODEL 405 (K904606) — FDA 510(k) | Innolitics, K904606 FDA 510(k) - MODEL 405 | Ivy Biomedical Systems, Inc., PDF K904606 MODEL 405 - 510kdatabase.net, PATIENT MONITOR MODEL 405P by IVY BIOMEDICAL SYSTEMS, INC. | FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K904606 | Class II | Active |
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Manufacturer
- Manufacturer
- Ivy Biomedical Systems, Inc.
Sources (1)
- FDA 510(k) K904606 24 fields · synced Sep 18, 2026