Identifiers
- 510(k) Number
- K203653 FDA 510(k)
- FDA Product Code
- LNH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MRI PPG Patient Cable is a System, Nuclear Magnetic Resonance Imaging device designed for photoplethysmography (PPG) monitoring during MRI procedures. It facilitates cardiac gating by transmitting pulse waveform data from patients to imaging systems, ensuring synchronized image acquisition with cardiac cycles for improved diagnostic clarity.
This cable is intended for single-use in MRI environments and must be compatible with MRI safety standards. Supplied sterile, it connects to PPG sensors and imaging systems, requiring no additional preparation beyond standard MRI patient setup. Authorized under FDA 510(k) clearance (K203653) as a Class 2 Radiology device (product code LNH), it adheres to regulation 892.1000 and is intended exclusively for use in MRI settings as specified.
Frequently asked questions
What is the primary purpose of the MRI PPG Patient Cable in an MRI setting?
The MRI PPG Patient Cable is designed specifically for photoplethysmography (PPG) monitoring during MRI procedures. Its main function is to transmit pulse waveform data from patients to imaging systems, enabling cardiac gating. This synchronization ensures that MRI images are acquired in alignment with the patient’s cardiac cycles, improving diagnostic clarity by reducing motion artifacts and enhancing image quality.
Is the MRI PPG Patient Cable intended for reuse, or is it meant to be used only once?
The MRI PPG Patient Cable is explicitly intended for single-use only. This design choice aligns with standard MRI safety protocols and ensures sterility and reliability for each procedure, as it is supplied sterile and requires no additional preparation beyond typical MRI patient setup.
How many different models or sizes of the MRI PPG Patient Cable are available, and are they interchangeable?
The device data lists multiple registration numbers (e.g., 3008156140, 3021593788, etc.), which typically correspond to different models or variants of the cable. While the exact specifications (e.g., length, connector types) aren’t detailed here, these variations suggest there may be multiple sizes or configurations available. However, interchangeability would depend on compatibility with the MRI system and PPG sensors in use—buyers should confirm with Ivy Biomedical Systems which models are compatible with their specific setup.
How should the MRI PPG Patient Cable be stored, and are there any special handling requirements?
Since the cable is supplied sterile, it should be stored in its original, sealed packaging to maintain sterility until use. The manufacturer’s instructions (not provided here) would outline any additional storage conditions, such as temperature or humidity constraints. As a single-use device, it should not be reused or restocked after opening. Always follow Ivy Biomedical Systems’ guidelines for proper handling to ensure MRI safety and device performance.
What regulatory pathway was followed for FDA clearance of the MRI PPG Patient Cable, and what does this mean for users?
The MRI PPG Patient Cable received FDA 510(k) clearance (K203653) under the Traditional pathway, classified as a Class 2 Radiology device (product code LNH). This means the device was determined to be substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness. For users, this clearance indicates the device adheres to FDA regulations (e.g., 892.1000) and is authorized for use in MRI environments as described, though it does not imply any specific clinical indication beyond its intended purpose.
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: K203653 - MRI PPG Patient Cable | FDA 510 (k), PDF K203653 MRI PPG Patient Cable - 510kdatabase.net, MRI PPG Patient Cable 510 (k) K203653 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203653 | Class II | Active |
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Manufacturer
- Manufacturer
- Ivy Biomedical Systems, Inc.
Sources (1)
- FDA 510(k) K203653 24 fields · synced Sep 18, 2026