PROMAXO, INC.

FDA Device Registration & Listing · Oakland, CA, US · Registration 3014635027

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
3014635027
FEI Number
3014635027
Entity Name
PROMAXO, INC.
City/State/Country
Oakland, CA, US
Establishment Address
70 Washington Street, Ste 407, Oakland, CA 94607, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Promaxo, Inc. (Owner Number: 10082446)
Owner / Operator Contact Address
70 Washington Street, Ste 407, Oakland, CA 94607, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K202518
PMA Number
N/A

All Registered Proprietary Names

Promaxo MRI System

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 2021-07-28
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2021-07-28

Official Correspondent

Veronica Sanz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Promaxo, 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014635027. Last updated year: 2026. Please use registration number 3014635027 when referencing this establishment in official correspondence.
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