Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list NRT X-RAY A/S with 4 device recalls and 2 510(k) clearances. The most recent is a 510(k) clearance dated Dec 23, 2024: Adora DRFi (04550010).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 23, 2024 | Adora DRFi (04550010)K242948 · JAA | 510(k) clearances |
| Apr 17, 2024 | Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray systemClass II · X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Mo | Device recalls |
| Apr 27, 2023 | Intelli-C, Left side suspended Tabletop, REF: 03400010Class II · There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which ca | Device recalls |
| Apr 27, 2023 | Intelli-C, Right side suspended Tabletop, REF: 03400000Class II · There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which ca | Device recalls |
| Jan 21, 2022 | 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C deClass II · Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table wh | Device recalls |
| Jul 11, 2018 | Intelli-CK173631 · OWB | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
