CMR NAVISCAN CORPORATION

FDA Device Registration & Listing · Carlsbad, CA, US · Registration 3005945241

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
3005945241
FEI Number
3005945241
Entity Name
CMR NAVISCAN CORPORATION
City/State/Country
Carlsbad, CA, US
Establishment Address
2720 Loker Ave W Ste O, Carlsbad, CA 92010, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
CMR Naviscan Corporation (Owner Number: 10045732)
Owner / Operator Contact Address
2720 Loker Ave W Ste O, Carlsbad, CA 92010, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K082354
PMA Number
N/A

All Registered Proprietary Names

LumaGEM MBI Software

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 2017-12-30
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2013-12-20

Official Correspondent

Larry Lugo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CMR Naviscan Corporation
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-0041-2008 Naviscan PET Systems 2
PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging.
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).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005945241. Last updated year: 2026. Please use registration number 3005945241 when referencing this establishment in official correspondence.
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