OTOM Co., Ltd.

FDA Device Registration & Listing · Gwangju, KR · Registration 3015537309

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
3015537309
FEI Number
3015537309
Entity Name
OTOM Co., Ltd.
City/State/Country
Gwangju, KR
Establishment Address
2F, 29, 880 bungil, Woochi-ro, Buk-gu, Gwangju 61042, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
OTOM Co., Ltd. (Owner Number: 10060836)
Owner / Operator Contact Address
2F, 29, 880 bungil, Woochi-ro, Buk-gu, Gwangju, KR-29 61042, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K213405
PMA Number
N/A

All Registered Proprietary Names

MINE ALNU

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2022-07-31

Official Correspondent

No official correspondent registered.

US Agent Details

Dave Kim Business: Mtech Group LLC Email: davekim@mtechgroupllc.com Phone: (713) 4672607

Related Public Records

Same Entity

OTOM Co., Ltd.
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
K153059 Minxray, Inc. HF1202H PowerPlus Portable X-ray Equipment 2016-02-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015537309. Last updated year: 2026. Please use registration number 3015537309 when referencing this establishment in official correspondence.
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