Data / Medical devices / Denmark / NRT X-Ray A/S
NRT X-Ray A/S: FDA-registered device maker in HASSELAGER Midtjylland, Denmark, 3 510(k) clearances
NRT X-Ray A/S is registered with the FDA (registration 1000188474) in HASSELAGER Midtjylland, Denmark. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 23, 2024. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000188474
- Address
- Birkegaardsvej 16, HASSELAGER Midtjylland, Denmark, 8361
- Owner or operator
- NRT X-RAY A/S (9059076)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 14, 2007
- Registered through
- 2026
- Brand names listed
- Adora DRFi, GE PRECISION MPI, Intelli C
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| December 23, 2024 | K242948 | Adora DRFi (04550010) | JAA | Substantially Equivalent | Nrt X-Ray A/S | accessdata.fda.gov |
| July 11, 2018 | K173631 | Intelli-C | OWB | Substantially Equivalent | Nrt X-Ray A/S | accessdata.fda.gov |
| November 19, 2003 | K033486 | GE PRECISION MPI | OWB | Substantially Equivalent | Nrt-Nordisk Rontgen Teknik A/S | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 17, 2024 | 94363 | Class II | Ongoing | Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system | 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 t | accessdata.fda.gov |
| April 27, 2023 | 92230 | Class II | Ongoing | Intelli-C, Right side suspended Tabletop, REF: 03400000 | 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. | accessdata.fda.gov |
| January 21, 2022 | 89413 | Class II | Ongoing | 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices) | 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. | accessdata.fda.gov |
| May 1, 2009 | 52173 | Not yet classified | Terminated | Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular | The GE Precision MPi is in violation with 21 CFR Part 1020.32 requiring a signal audible to the fluoroscopist to sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Interventional Fluoroscopic X-Ray System
Updated December 23, 2024. 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.