Identity
- Trade Name
- Communication Control FDA UDI
- Generic Name
- Headphones FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 22 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856181003220 FDA UDI
- 510(k) Number
- K133670 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Headphones FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Headphones
Communication Control by Neocoil, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Headphones.
- MRIaudio Over-Ear Headphones — Mriaudio · Class II
- Wishbone Headset — Mriaudio · Class II
- MRIaudio Ear-Tip — Mriaudio · Class II
- Battery Charger — NEOCOIL, LLC · Class II
- Technologist Console Interface — NEOCOIL, LLC · Class II
- Wireless Audio Interface — NEOCOIL, LLC · Class II
- Router Assembly — NEOCOIL, LLC · Class II
- Stand-Alone Wireless Audio Headphones — NEOCOIL, LLC · Class II
Cleared under the same submission
K133670 also covers:
- Battery Charger — NEOCOIL, LLC
- PCE Pen Panel Transmitter Box — NEOCOIL, LLC
- Pen Panel Transmitter Box — NEOCOIL, LLC
- Siemens audio module — NEOCOIL, LLC
- Stand-Alone Wireless Audio Headphones — NEOCOIL, LLC
- Stand-Alone Wireless Patient Alert — NEOCOIL, LLC
- Tech Console — NEOCOIL, LLC
- Wireless Audio Interface — NEOCOIL, LLC
- Wireless Headphones — NEOCOIL, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Neocoil, Llc
Sources (1)
- FDA UDI 939edac5-8360-4c52-87e5-616000f47610 34 fields · synced May 31, 2026