# K140683: 0180 Intuition, 0072 Precision

- Pathway: 510(k) (Special)
- Applicant: Arcoma AB
- Decided: Jun 3, 2014 after 77 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K042041 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073632: Intuition, Model 0170, Arcoma AB (2008) Summary page 1.

## Recalls of this device
- May 5, 2021 · Class II · Z-1332-2022: There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).
- May 5, 2021 · Class II · Z-1331-2022: There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).

## Indications for use
These are stationary x-ray systems intended for obtaining radiographic images of various portions of the human body in a clinical environment. The devices are not intended for mammography

Source page: https://510kreport.com/device/K140683
Methodology: https://510kreport.com/methodology