Nrt X-Ray A/S
DenmarkFDA applicant, unverified FDA FEI 1000188474
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 44 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Nrt X-Ray A/S makes
Nrt X-Ray A/S manufactures digital radiography systems, including the Intelli-C—a portable X-ray device—and the Adora DRFi, a fixed digital radiography system designed for high-resolution imaging.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Intelli-C Ref K173631
Regimes: 510(k) Registry: 510(k)Adora DRFi (04550010) Ref K242948
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1000188474
- Address
- BIRKEGAARDSVEJ 16, HASSELAGER Midtjylland
FDA recalls
FDA recall records list 4 recalls initiated by Nrt X-Ray A/S, the earliest on 2022-01-21 and the most recent on 2024-04-17. By recorded status: 4 ongoing. The reasons filed fall into these groups: software or firmware and mechanical integrity. 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 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 2
- 2024 1
- 2025 0
- 2026 0
2024
- 17 Apr 2024 Z-1784-2024 Class II Ongoing X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.
2023
- 27 Apr 2023 Z-1668-2023 Class II Ongoing There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.
- 27 Apr 2023 Z-1669-2023 Class II Ongoing There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.
2022
- 21 Jan 2022 Z-0526-2022 Class II Ongoing Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C, Left.
Frequently asked questions
How many devices does Nrt X-Ray A/S have in the registry?
The registry currently lists 2 devices for Nrt X-Ray A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nrt X-Ray A/S's devices?
Among its 2 most recently registered devices, Nrt X-Ray A/S has devices listed in FDA 510(k) (2 devices).
What risk classes do Nrt X-Ray A/S's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Nrt X-Ray A/S's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Nrt X-Ray A/S?
FDA recall records list 4 recalls initiated by Nrt X-Ray A/S, the most recent initiated on 17 Apr 2024. 4 of them are recorded as ongoing. 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 Nrt X-Ray A/S in the registry?
The most recently registered devices listed for Nrt X-Ray A/S include Intelli-C and Adora DRFi (04550010).