Identifiers
- 510(k) Number
- K132444 FDA 510(k)
- FDA Product Code
- MOS 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 Atama System is a Magnetic Resonance, Specialty Coil designed for neurosurgical applications. It provides a specialized coil interface for MRI imaging, enabling high-resolution scans of the head while maintaining patient immobilization during transport between operating rooms, transport gurneys, and MRI couches.
This device is intended for single-use in MRI-compatible environments, compatible with 1.5T or 3.0T MRI systems. It is classified as a Class II medical device under FDA regulations (892.1000) and holds a 510(k) clearance (K132444) for substantial equivalence in radiology applications. Sterility and regulatory compliance are ensured through FDA-authorized manufacturing processes.
Frequently asked questions
What is the Atama System used for in MRI procedures?
The Atama System is a specialized MRI coil designed specifically for neurosurgical applications. It provides a high-resolution imaging interface for the head, enabling detailed scans while maintaining patient stability during transport between operating rooms, transport gurneys, and MRI couches. This ensures consistent imaging quality and reduces the risk of movement artifacts during critical procedures.
Is the Atama System compatible with all MRI machines?
The Atama System is designed for use with MRI systems operating at 1.5 Tesla (T) or 3.0 Tesla (T). It is not universally compatible with every MRI machine, so compatibility should be verified with your specific system’s manufacturer or technical specifications before use.
How is the Atama System supplied, and is it sterile?
The Atama System is supplied as a single-use device, ensuring sterility and compliance with FDA-authorized manufacturing processes. Each unit is intended for one-time use in MRI-compatible environments to maintain hygiene and regulatory standards.
Can the Atama System be reused after a single procedure?
No, the Atama System is explicitly designed for single-use only. Reusing it could compromise sterility, imaging accuracy, and patient safety. Always follow the manufacturer’s guidelines for proper disposal after one use.
What regulatory approvals does the Atama System hold?
The Atama System holds a 510(k) clearance (K132444) from the FDA, demonstrating substantial equivalence in radiology applications under the classification of Class II medical devices (892.1000). This approval ensures it meets regulatory standards for safety and performance in MRI environments.
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: PDF AtamA - Instructions for Use - monteris.com, PDF AtamA - Instructions for Use - Monteris, Head MRI coil AtamA™ Monteris Medical - HealthManagement.org
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132444 | Class II | Active |
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Manufacturer
- Manufacturer
- Monteris Medical,
Sources (1)
- FDA 510(k) K132444 24 fields · synced Oct 1, 2026