# K890348: LC, Cardiac Positioner #B5078A

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Feb 27, 1989 after 35 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
331 later devices descend from it; 1 cites it directly.
10 of 332 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K993037: LCV+ Version 2 (2000), 330 descendants of its own
- K021021: Modular Angiography System Axiom Artis (2002), 218 descendants of its own
- K020055: Philips Integris Allura 9 with FD Option (2002), 124 descendants of its own
- K022899: Philips Integris Allura Flat Detector Release 1.0 (2002), 114 descendants of its own
- K031333: Philips Integris Allura Flat Detector Release 1.2 (2003), 113 descendants of its own

## Recalls of this device
- Mar 24, 2004 · Not classified · Z-0896-04: Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox.
- Mar 24, 2004 · Not classified · Z-0897-04: Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox.
- Mar 24, 2004 · Not classified · Z-0898-04: Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox.
- Mar 24, 2004 · Not classified · Z-0899-04: Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox.
- Mar 24, 2004 · Not classified · Z-0900-04: Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox.

Source page: https://510kreport.com/device/K890348
Methodology: https://510kreport.com/methodology