# K173631: Intelli-C

- Pathway: 510(k) (Traditional)
- Applicant: Nrt X-Ray A/S
- Decided: Jul 11, 2018 after 229 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961374 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033486: GE Precision Mpi, Nrt-Nordisk Rontgen Teknik A/S (2003) Summary page 4.

## Recalls of this device
- Apr 17, 2024 · Class II · Z-1784-2024: 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 angula
- Apr 27, 2023 · Class II · Z-1669-2023: 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.
- Apr 27, 2023 · Class II · Z-1668-2023: 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.
- Jan 21, 2022 · Class II · Z-0526-2022: 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, Rig

## Indications for use
The Intelli-C is indicated for use as a multipurpose diagnostic X-ray system for universal radiographic, radioscopic and fluoroscopic studies. With its C-arm and digital flat detector, it can perform a range of applications including interventional procedures, vascular and non-vascular procedures, specialized applications including angiographic studies of the entire body on adults and paediatrics. The Intelli-C system is only indicated for use by trained professionals. The Intelli-C is not intended for mammography studies.

Source page: https://510kreport.com/device/K173631
Methodology: https://510kreport.com/methodology