Konica Minolta Healthcare Americas, Inc

FDA Device Registration & Listing · Garner, NC, US · Registration 1064396

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
1064396
FEI Number
3002885429
Entity Name
Konica Minolta Healthcare Americas, Inc
City/State/Country
Garner, NC, US
Establishment Address
2217 Us Highway 70 E, Garner, NC 27529, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Konica Minolta Healthcare Americas, Inc. (Owner Number: 2241281)
Owner / Operator Contact Address
411 NEWARK-POMPTON TURNPIKE, --, Wayne, NJ 07470, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K142919
PMA Number
N/A

All Registered Proprietary Names

OPAL-RAD OTC DDR ONYX-RAD TELEMEDICINE PACS ViZion DR + Wireless VIZION DR ViZion DR + Wireless VIZTEK WL Straight Arm DDR KDR AU-DDR System Advanced U-Arm With Dynamic Digital Radiography, KDR AU System Advanced U-Arm With Static Digital Radiography VIZTEK DR, MODELS: DR1000, DR3000, DR4000 VIZION DR VIZION + DR EXA or Symmetry PACS

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 2017-08-23
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2022-11-30
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-11-30
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2017-08-23
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2017-08-23
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2017-08-23
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2017-08-23
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2017-08-23
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2017-08-23
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2022-11-30
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-11-30
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2020-04-09
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2020-04-09
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2017-08-23
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2017-08-23
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2017-08-23
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2017-08-23
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2017-08-23

Official Correspondent

Jan Maniscalco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Konica Minolta Healthcare Americas, Inc.
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 1064396. Last updated year: 2026. Please use registration number 1064396 when referencing this establishment in official correspondence.
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