INFINITT HEALTHCARE CO., LTD.

FDA Device Registration & Listing · SEOUL, KR · Registration 3003989064

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
3003989064
FEI Number
3003989064
Entity Name
INFINITT HEALTHCARE CO., LTD.
City/State/Country
SEOUL, KR
Establishment Address
12F Daerung Post Tower III, 27 Digital-ro 34-gil, Guro-gu, Seoul, 08378, South Korea, SEOUL 08378, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
INFINITT Healthcare Co., Ltd. (Owner Number: 9055477)
Owner / Operator Contact Address
12F Daerung Post Tower III, 182-4, Guro-Dong, Guro-Gu, SEOUL, KR-NOTA 08378, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K193369
PMA Number
N/A

All Registered Proprietary Names

XELIS DENTAL Xelis Cardiac Xelis Fusion INFINITT ULite ULite STARPACS Dental INFINITT RT Mobile INFINITT Cardiology PACS INFINITT Cardiology STARPACS Orthopedics System STARPACS INFINITT RT PACS Xelis 3D INFINITT MAMMO 7 INFINITT G7 PACS INFINITT PACS 7 INFINITT DPS Xelis Dental 2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2011-02-20
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-01-07
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-01-07
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2017-04-14
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2011-02-20
LMD System, Digital Image Communications, Radiological Radiology Class 1 892.2020 2022-08-23
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2011-02-20
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2011-02-20
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2011-02-20
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-03-17
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-01-07
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2017-12-03
QKQ Digital Pathology Image Viewing And Management Software Pathology Class 2 864.3700 2025-12-10
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-04-23

Official Correspondent

JinJun Kim

US Agent Details

David Smarro Business: David Smarro Email: dsmarro@infinittNA.com Phone: (908) 3876960

Related Public Records

Same Entity

INFINITT Healthcare 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
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23
K961871 Siemens Medical Solutions USA, Inc. FLOUROSPOT T.O.P. 1996-07-31
K122260 Aycan Digitalsysteme GmbH AYCAN MOBILE 2012-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003989064. Last updated year: 2026. Please use registration number 3003989064 when referencing this establishment in official correspondence.
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