Gem Option For 1.5 Mri Systems
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103335 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 GEM Option for 1.5T MRI Systems is a set of Magnetic Resonance, Specialty Coil (FEI classification) designed for receive-only radiofrequency (RF) signal reception. These coils are engineered to enhance imaging resolution and sensitivity for specific anatomical regions, including the head, neck, spine, pelvis, and extremities, within 1.5-tesla MRI environments. Their specialty design optimizes signal-to-noise ratio for targeted diagnostic applications.
Supplied as a modular accessory for GE Healthcare’s 1.5T MRI systems, the GEM Option is intended for single-use or reusable configurations depending on coil type (as indicated by FEI numbers). All coils are MRI-compatible and must be used within the specified magnetic field strength. Sterility and regulatory compliance are ensured through FDA 510(k) clearance (K103335), with classification under Class II (MOS product code). Storage and handling follow manufacturer guidelines to maintain coil integrity and performance.
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: K103335 FDA 510(k) - GEM OPTION FOR 1.5 MRI SYSTEMS, GEM OPTION FOR 1.5 MRI SYSTEMS - fda.innolitics.com, PDF K103335 - GEM OPTION FOR 1.5 MRI SYSTEMS - 510kdatabase.net, GE MRI Protocols and Imaging Options
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103335 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GE Healthcare
Sources (1)
- FDA 510(k) K103335 24 fields · synced Oct 6, 2026