Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009117933

FEI Number

3009117933

Entity Name

LUNIT INTERNATIONAL LIMITED

City/State/Country

Wellington Central, NZ

Establishment Address

Level 4, 1 Victoria Street, Wellington Central 6011, NZ

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Lunit International Limited (Owner Number: 10034313)

Owner / Operator Contact Address

Level 4, 1 Victoria Street, Wellington Central, NZ-WGN 6011, NZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153427

PMA Number

N/A

All Registered Proprietary Names

Volpara Live Volpara Scorecard Volpara Scorecard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2013-12-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-07-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-03-13

Official Correspondent

No official correspondent registered.

US Agent Details

Sheila Pickering Email: sheilawalshpickering@gmail.com Phone: (650) 2790668

Related Public Records

Same Entity

Lunit International Limited

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)

Similar Registrations

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3003920322	VACUTEC MESSTECHNIK GMBH	DRESDEN Saxony, DE
3042175844	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
2184007	STANDARD IMAGING, INC.	MIDDLETON, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009117933. Last updated year: 2026. Please use registration number 3009117933 when referencing this establishment in official correspondence.