DXTX MEDICAL INC.

FDA Device Registration & Listing · Pittsburgh, PA, US · Registration 3015431711

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
3015431711
FEI Number
3015431711
Entity Name
DXTX MEDICAL INC.
City/State/Country
Pittsburgh, PA, US
Establishment Address
639 Alpha Drive, Pittsburgh, PA 15238, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
DxTx Medical Inc. (Owner Number: 10061391)
Owner / Operator Contact Address
639 Alpha Drive, Pittsburgh, PA 15238, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K063342
PMA Number
N/A

All Registered Proprietary Names

e2Coil Imaging System for the Siemens MAGNETOM 3T MRI Systems with Tim 4G Connector Pro-Tx Endorectal Balloon 1.5T eCoil Imaging System Disposables Colon 1.5 eCoil Imaging System Disposables Cervix 1.5T Imaging Device for Siemens 3T eCoil Imaging Device for GE 1.5 T eCoil Imaging System for Philips

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 2025-07-18
PCT Prostate Immobilizer Rectal Balloon Radiology Class 2 892.5720 2023-03-08
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-10-14
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-10-14
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-10-14
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2019-10-14
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2019-10-14

Official Correspondent

Paul Lawson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DxTx Medical 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 3015431711. Last updated year: 2026. Please use registration number 3015431711 when referencing this establishment in official correspondence.
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