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Temporomanibular Coil 15

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K110373

by Esaote S.p.A.

Identifiers

510(k) Number
K110373 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 Temporomandibular Coil 15 is a Magnetic Resonance, Specialty Coil designed for temporomandibular joint (TMJ) imaging. As a single-channel surface receiving coil, it is engineered to optimize signal-to-noise ratio (SNR) by conforming to the anatomical contours of the joint, enhancing diagnostic clarity in MRI scans.

This device is intended for use with the S-scan MR system as a passive receiver of magnetic resonance signals, processed by the host system to generate cross-sectional images. Supplied as a reusable accessory, it adheres to FDA 510(k) clearance (K110373) and is classified under product code MOS (Moderate Risk, Radiology). Compliance with MDR and MDD regulations is also noted, ensuring adherence to European medical device standards.

Frequently asked questions

What is the primary purpose of the Temporomandibular Coil 15 in MRI imaging?

The Temporomandibular Coil 15 is specifically designed to enhance MRI imaging of the temporomandibular joint (TMJ). As a single-channel surface receiving coil, it improves signal-to-noise ratio (SNR) by conforming closely to the joint’s anatomical contours, which helps clinicians obtain clearer and more detailed cross-sectional images for diagnostic evaluation.

Is the Temporomandibular Coil 15 intended for single-use or reusable applications?

The Temporomandibular Coil 15 is supplied as a reusable accessory for MRI systems. Since it is not labeled as disposable, proper cleaning and maintenance protocols must be followed to ensure consistent performance and compliance with regulatory standards.

Which MRI systems is this coil compatible with, and how is it used?

The coil is designed exclusively for use with the S-scan MR system as a passive receiver of magnetic resonance signals. It does not generate images independently but works in conjunction with the host system to process signals and produce cross-sectional TMJ images, improving diagnostic accuracy.

What regulatory pathways does this device follow, and what does that mean for buyers?

The coil follows FDA 510(k) clearance (K110373) under the Moderate Risk (MOS) product code, meaning it has been deemed substantially equivalent to a predicate device. It also complies with MDR (Medical Device Regulation) and MDD (Medical Device Directive) standards in Europe, ensuring adherence to both U.S. and EU medical device regulations. Buyers should confirm local compliance requirements before use.

Are there multiple versions or sizes of this coil, or is it a single model?

The provided data does not specify multiple sizes or models for the Temporomandibular Coil 15, indicating it is likely a single, standardized design optimized for TMJ imaging. However, the OpenFDA registration numbers suggest it may have been distributed under various lot or batch identifiers, but no variations in coil dimensions or configurations are mentioned.

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: TEMPOROMANIBULAR COIL 15 (K110373) — FDA 510 (k) | Innolitics, TMJ COIL N. 15 — FDA Class II Medical Device | MedEquip Directory, PDF K110373 TEMPOROMANIBULAR COIL 15 - 510kdatabase.net, Esaote Temporomanibular Coil 15 - allmed.wiki

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Esaote S.p.A.
FDA Applicant
Esaote, S.p.A.

Sources (2)

  • FDA 510(k) K110373 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026