FDA.reportPublic FDA data

Wireless Audio Interface

Primary DI
00856181003398
Brand
Wireless Audio Interface
Company
NEOCOIL, LLC
Model
39
Device description
The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
Published
2017-03-16
Public version status
Update
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
K133670000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133670000HEADPHONES, PATIENT ALERT, STANDALONE INTERFACENeocoil, LLC2014-07-24LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856181003398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856181003398008561810033988561810033980856181003398

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
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
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.LNH2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.LNH2026-04-22
B319QSM1QSMetricIMAGING BIOMETRICS, LLCLNH2026-04-22
10841962119457Symphony Locating Bar, Prodigy2™QfixLNH2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixLNH2025-10-23
10841439114732PronumbraMEDTEC, INC.LNH2025-09-12
10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12
10841439114787PronumbraMEDTEC, INC.LNH2025-09-12
08056304455727G-scan OpenESAOTE SPALNH2024-07-02
10841962119433Leg ExtensionQfixLNH2023-08-17
10841962119440Leg ExtensionQfixLNH2023-08-17
09355529000002FerriScan, Cardiac T2*RESONANCE HEALTH ANALYSIS SERVICES PTY LTDLNH2023-06-19