# K944013: CT Prospeed Family

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Feb 7, 1995 after 175 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K963896: Mobile CT Prospeed Family (1996), 0 descendants of its own
- K961055: CT Prospeed CT/I (1996), 0 descendants of its own

## Recalls of this device
- Dec 1, 2008 · Not classified · Z-2224-2009: During internal testing, GE Healthcare has recently determined that the collimator used on our CT/e and HiSpeed X/i families of Computed Tomography systems does not comply with the specific requiremen
- Oct 21, 2004 · Not classified · Z-0269-05: The patient tables of the affected CT systems are supported by a hydraulic cylinder and a cylinder shaft (i.e. the upper shaft) which connects the tabletop to the table frame. GE received a report of 

Source page: https://510kreport.com/device/K944013
Methodology: https://510kreport.com/methodology