Chrysalis Intelligence · Sponsors · Nrt X-Ray A/S

Nrt X-Ray A/S

Hasselager, DK · 1 510(k) clearances · 4 recalls

Total clearances
1
2024-12-23 → 2024-12-23
Last 12 months
0
Product codes
1
Most recent
2024-12-23
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
JAA System, X-Ray, Fluoroscopic, Image-Intensified Class II Radiology 1 2024-12-23
Safety

Recalls (4)

Class I (serious)
0
Risk of injury / death
Total recalls
4
Currently ongoing
4
Most recent
2024-04-17
DateSeverityStatusRecall # ProductCodeReason
2024-04-17 Class II Ongoing Z-1784-2024 Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Inte… 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 moveme…
2023-04-27 Class II Ongoing Z-1669-2023 Intelli-C, Left side suspended Tabletop, REF: 03400010 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 …
2023-04-27 Class II Ongoing Z-1668-2023 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 …
2022-01-21 Class II Ongoing Z-0526-2022 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combinati… 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 accessor…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2024-12-23 K242948 Adora DRFi (04550010) JAA Class II Radiology