ANDA Medical

FDA Device Registration & Listing · Oshawa Ontario, CA · Registration 3015223550

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
3015223550
FEI Number
3015223550
Entity Name
ANDA Medical
City/State/Country
Oshawa Ontario, CA
Establishment Address
330 Marwood Dr., Unit 4, Oshawa Ontario L1H 8B4, CA
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
ANDA Medical (Owner Number: 10083854)
Owner / Operator Contact Address
330 Marwood Drive, Unit 3, Oshawa, CA-ON L1H8B4, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K133819
PMA Number
N/A

All Registered Proprietary Names

CARESTREAM DRX REVOLUTION MOBILE XRAY SYSTEM GE Lightspeed VCT CT GE 1.5T Twinspeed MRI GE OPTIMA XR 220AMX PORTABLE XRAY MACHINE Philips Veradius C-Arm

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2026-04-16
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2026-04-16
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-08-13
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-12-05
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2026-04-16
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2025-11-19
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2025-11-19
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2025-11-19

Official Correspondent

Taylor Bailie

US Agent Details

Samuel Fish Email: samuel@shieldsecuritydoors.com Phone: (866) 6391507

Related Public Records

Same Entity

ANDA Medical
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
K070563 Vidar Systems Corp. VIDAR VISION 2000 2007-03-16
K190691 Pixxgen Corporation Pixx2430 Digital Diagnostic X-Ray Receptor Panel 2019-04-04
K150150 Rayence Co., Ltd. 1717SGN / 1717SCN Digital Flat Panel X-ray Detector 2015-03-27
K140771 Philips Medical Systems Dmc GmbH PHILIPS ELEVA WORKSPOT 2014-04-25
K153059 Minxray, Inc. HF1202H PowerPlus Portable X-ray Equipment 2016-02-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2009 Toshiba American Medical Systems Inc 2
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007 AGFA Corp. 2
CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-1470-2023 FUJIFILM Healthcare Americas Corporation 2
FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024 FUJIFILM Healthcare Americas Corporation 2
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Z-0007-2011 GE Medical Systems, LLC 2
HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.

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9614698 CANON INC. OTAWARA-SHI Tochigi, JP
3003775006 FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office HANAMAKI-SHI Iwate, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015223550. Last updated year: 2026. Please use registration number 3015223550 when referencing this establishment in official correspondence.
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