POLAREAN, INC.

FDA Device Registration & Listing · Durham, NC, US · Registration 3010132318

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010132318
FEI Number
3010132318
Entity Name
POLAREAN, INC.
City/State/Country
Durham, NC, US
Establishment Address
2500 Meridian Pkwy, #175, Durham, NC 27713, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Polarean, Inc. (Owner Number: 10087679)
Owner / Operator Contact Address
2500 Meridian Pkwy, #175, Durham, NC 27713, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K223071
PMA Number
N/A

All Registered Proprietary Names

XENOVIEW 3T Chest Coil XENOVIEW 3T Chest Coil XENOVIEW 3T Chest Coil Xenoview VDP

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2024-11-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2024-11-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2025-12-17
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2023-03-27

Official Correspondent

Amanda Morris

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Polarean, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K121249 Paramed S.R.L. MULTIARRAY KIT 2012-06-12
K000935 Mri Devices Corp. KFA-63 KNEE AND FOOT ARRAY 2000-04-07
K102889 Hitachi Medical Systems America, Inc. HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON 2010-12-20
K110373 Esaote, S.p.A. TEMPOROMANIBULAR COIL 15 2011-04-06
K030317 Midwest Rf, LLC MODEL 1300GE-64: PEDIATRIC POSITIONER 2003-03-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2020 Quality Electrodynamics LLC 2
TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Z-0032-2020 Quality Electrodynamics LLC 2
TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
Z-0033-2020 Quality Electrodynamics LLC 2
TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Z-0034-2020 Quality Electrodynamics LLC 2
TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
Z-0035-2020 Quality Electrodynamics LLC 2
TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525

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3010949642 GE HEALTHCARE (TIANJIN) COMPANY LIMITED Tianjin, CN
3006369484 NEOCOIL, LLC Pewaukee, WI, US
3010703925 MAKAR CONSULTING PTY LTD Belrose New South Wales, AU
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010132318. Last updated year: 2026. Please use registration number 3010132318 when referencing this establishment in official correspondence.
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