Konica Minolta Healthcare Americas, Inc
Country not established FDA establishment FEI 3002885429
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 2
What Konica Minolta Healthcare Americas, Inc makes
Konica Minolta Healthcare Americas, Inc manufactures digital radiography systems, including portable and fixed-arm units for dynamic and static imaging. Their portfolio includes systems like the KDR AU-DDR and KDR AU systems, as well as standalone digital detectors such as the Universal DR 1748 and OTC DDR. These devices are designed for X-ray imaging in clinical settings, supporting both mobile and stationary applications. Additional offerings include the Straight Arm DDR and EXA series, which cater to specialized radiographic needs.
The company’s devices fall under FDA Class II classification and are authorised through the 510(k) pathway in the United States. These products are registered with the FDA’s 510(k) clearance system, ensuring compliance with regulatory requirements for medical imaging equipment. The manufacturer operates from its base in the United States.
Catalogue
Universal 1417PI Ref K252996
510(k) 510(k)- 510(k) 510(k)
Universal DR 1748 Ref K214030
510(k) 510(k)Otc Ddr Ref K221853
510(k) 510(k)Straight Arm DDR Ref K214012
510(k) 510(k)Exa Ref K203743
510(k) 510(k)
Company details
- FDA FEI number
- 3002885429
- Address
- 2217 Us Highway 70 E, Garner, NC, 27529
FDA recalls
FDA recall records list 2 recalls initiated by Konica Minolta Healthcare Americas, Inc, the earliest on 2018-11-08 and the most recent on 2021-12-03. By recorded status: 2 terminated. The reasons filed fall into these groups: electrical or power and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 3 Dec 2021 Z-0500-2022 Class II Terminated lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power sequence is followed
2018
- 8 Nov 2018 Z-0659-2019 Class II Terminated Unintentional U-Arm movement
Full distribution text
- 8 Nov 2018 Z-0659-2019 Class II Terminated Unintentional U-Arm movement
Frequently asked questions
How many devices does Konica Minolta Healthcare Americas, Inc have in the registry?
The registry currently lists 6 devices for Konica Minolta Healthcare Americas, Inc. Devices recorded under merged duplicate company entries are counted once.
Which registries list Konica Minolta Healthcare Americas, Inc's devices?
Among its 6 most recently registered devices, Konica Minolta Healthcare Americas, Inc has devices listed in FDA 510(k) (6 devices).
What risk classes do Konica Minolta Healthcare Americas, Inc's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Konica Minolta Healthcare Americas, Inc's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Konica Minolta Healthcare Americas, Inc?
FDA recall records list 2 recalls initiated by Konica Minolta Healthcare Americas, Inc, the most recent initiated on 2021-12-03. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Konica Minolta Healthcare Americas, Inc in the registry?
The most recently registered devices listed for Konica Minolta Healthcare Americas, Inc include Universal 1417PI, KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography, Universal DR 1748 and OTC DDR.