FDA.reportPublic FDA data

Sentinel P2 Audio Interface Module

Primary DI
00856181003770
Brand
Sentinel P2 Audio Interface Module
Company
NEOCOIL, LLC
Model
77
Device description
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.
Published
2018-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173409000Wireless Audio SystemNeocoil, LLC2018-02-16LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856181003770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856181003770008561810037708561810037700856181003770

GMDN Terms#

Term, Definition table
TermDefinition
HeadphonesA device that is worn on the head, typically fitting over both ears, but that may fit over one ear. It supplies the user with audio input increasing the sound volume of, e.g., television, radio, or a communication amplifier.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
781155176
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008500289325371.5T 16ch Breast Coil53NC1492292025-11-18
0085002893249032ch AIR Open Coil Suite, 3.0T49NC1390202023-01-27
0085002893250632ch AIR Open Coil Suite, 1.5T50NC1390212023-01-27
008561810039301.5T 16ch Shoulder Coil (System)93NC1430012020-09-09
008561810039233.0T 16ch Shoulder Coil (System)92NC1430002020-07-17
008561810038931.5T 16Ch Breast Coil89M7006PH2019-06-10
008561810038243.0T 16ch Breast Coil82M7006PA2018-04-26
008500289324523T 16ch Breast Coil45NC1492092023-03-23
008500289324691.5T 16ch Breast Coil46NC1492292023-03-23
00850028932513Biopsy Grid Assembly, Pack, Breast Coil51NC1494442023-03-23
00850028932520Drape Pack, Biopsy, Breast Coil52NC1494752023-03-23
008500289322543.0T AIR Open Head Neck Posterior 9ch25NC1392002023-01-27
008500289322613.0T AIR Open Neck Chest Anterior 7ch26NC1392012023-01-27
008500289322783.0T AIR Open Head Anterior 16ch27NC1392022023-01-27
008500289322851.5T AIR Open Head Neck Posterior 9ch28NC1392032023-01-27
008500289322921.5T AIR Open Neck Chest Anterior 7ch29NC1392042023-01-27
008500289323081.5T AIR Open Head Anterior 16ch30NC1392052023-01-27
00856181003312ECG CT Gating Device312017-03-21
00856181003329ECG CT Gating Receiver322017-03-21
00856181003336ECG CT Gating Cable332017-03-21

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Primary DI, Brand, Company table
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08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
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