Data / Medical devices / United States / Konica Minolta Healthcare Americas, Inc
Konica Minolta Healthcare Americas, Inc: FDA-registered device maker in Garner, NC, United States, 15 510(k) clearances
Konica Minolta Healthcare Americas, Inc is registered with the FDA (registration 1064396) in Garner, NC, United States. It lists 3 device types. The FDA files 15 510(k) clearances under its listings, the newest dated June 12, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1064396
- FEI number
- 3002885429
- Address
- 2217 Us Highway 70 E, Garner, NC, United States, 27529
- Owner or operator
- Konica Minolta Healthcare Americas, Inc. (2241281)
- Roles
- Manufacturer
- First device listed
- August 23, 2017
- Registered through
- 2026
- Brand names listed
- EXA or Symmetry PACS, KDR AU-DDR System Advanced U-Arm With Dynamic Digital Radiography, KDR AU System Advanced U-Arm With Static Digital Radiography, ONYX-RAD TELEMEDICINE PACS, OPAL-RAD, OTC DDR, Straight Arm DDR, Universal 1417 PI, VIZION + DR and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2026 | K252996 | Universal 1417PI | MQB | Substantially Equivalent | Konica Minolta Healthcare Americas, Inc. | accessdata.fda.gov |
| July 27, 2022 | K221853 | OTC DDR | KPR | Substantially Equivalent | Konica Minolta Healthcare Americas, Inc. | accessdata.fda.gov |
| January 12, 2022 | K214012 | Straight Arm DDR | KPR | Substantially Equivalent | Konica Minolta Healthcare Americas, Inc. | accessdata.fda.gov |
| January 15, 2020 | K193225 | KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography | KPR | Substantially Equivalent | Konica Minolta Healthcare Americas, Inc. | accessdata.fda.gov |
| May 20, 2016 | K160810 | ViZion DR + Wireless | MQB | Substantially Equivalent | Viztek, LLC | accessdata.fda.gov |
| September 10, 2015 | K152279 | ViZion DR + Wireless | MQB | Substantially Equivalent | Viztek, LLC | accessdata.fda.gov |
| December 16, 2014 | K142919 | EXA | LLZ | Substantially Equivalent | Viztek, LLC | accessdata.fda.gov |
| April 3, 2014 | K133139 | VIZION ULTRA | MQB | Substantially Equivalent | Viztek, LLC | accessdata.fda.gov |
| January 11, 2013 | K123644 | VIZION + DR | MQB | Substantially Equivalent | Viztek, LLC | accessdata.fda.gov |
| October 20, 2011 | K112661 | VIZION DR | MQB | Substantially Equivalent | Viztek, LLC | accessdata.fda.gov |
| January 24, 2011 | K102123 | VIZION DR | KPR | Substantially Equivalent | Viztek, Inc. | accessdata.fda.gov |
| November 12, 2009 | K091752 | VIZTEK WL | KPR | Substantially Equivalent | Viztek, Inc. | accessdata.fda.gov |
| November 21, 2008 | K082604 | VIZTEK DR, MODELS: DR1000, DR3000, DR4000 | KPR | Substantially Equivalent | Viztek, Inc. | accessdata.fda.gov |
| December 12, 2006 | K063337 | OPAL-RAD | LLZ | Substantially Equivalent | Viztek, Inc. | accessdata.fda.gov |
| February 15, 2001 | K003607 | ONYX-RAD TELEMEDICINE PACS | LLZ | Substantially Equivalent | Viztek, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 8, 2018 | 81649 | Class II | Terminated | Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vert | Unintentional U-Arm movement | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Stationary
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, Image Processing, Radiological
Updated June 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.