AVOTEC, INC.

FDA Device Registration & Listing · STUART, FL, US · Registration 1055916

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
1055916
FEI Number
1000113348
Entity Name
AVOTEC, INC.
City/State/Country
STUART, FL, US
Establishment Address
609 N.W. BUCK HENDRY WAY, STUART, FL 34994, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AVOTEC, INC. (Owner Number: 9005386)
Owner / Operator Contact Address
609 N.W. BUCK HENDRY WAY, --, Stuart, FL 34994, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K921891
PMA Number
N/A

All Registered Proprietary Names

Silent Scan

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2008-05-21

Official Correspondent

STEPHANIE DRABIN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AVOTEC, 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
K033504 General Electric Co. GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM 2003-11-25
K013636 GE Medical Systems SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY 2002-01-24
K250443 Siemens Healthcare GmbH MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile 2025-06-16
K151015 Hitachi Medical Systems America, Inc. ECHELON Oval V 5.0 MRI System 2015-07-29
K910715 Philips Medical Systems (Cleveland), Inc. VISTA HPQ SYSTEM 1991-06-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0029-2007 Hitachi Medical Systems America Inc 2
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014 Philips Medical Systems (Cleveland) Inc 2
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024 Philips North America Llc 2
Achieva 1.5T
Z-0390-2024 Philips North America Llc 2
Achieva 1.5T Conversion
Z-0391-2024 Philips North America Llc 2
Achieva 1.5T Initial System

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1055916. Last updated year: 2026. Please use registration number 1055916 when referencing this establishment in official correspondence.
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