SCANMED, LLC

FDA Device Registration & Listing · Omaha, NE, US · Registration 1932898

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
1932898
FEI Number
1000158431
Entity Name
SCANMED, LLC
City/State/Country
Omaha, NE, US
Establishment Address
9840 S 140th St Ste 8, Omaha, NE 68138, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
DirectMed Imaging, LLC (Owner Number: 10088947)
Owner / Operator Contact Address
12525 Stowe Drive, Poway, CA 92064, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K142676
PMA Number
N/A

All Registered Proprietary Names

3T PROCURE coil

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 2023-11-13

Official Correspondent

Carlee Seeba

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DirectMed Imaging, LLC
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1932898. Last updated year: 2026. Please use registration number 1932898 when referencing this establishment in official correspondence.
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