# K924310: Prestilix 1694 D Image Intensified Fluorosccopic

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jan 21, 1993 after 148 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
133 later devices descend from it; 1 cites it directly.
0 of 134 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
- K960266: Siregraph CF (1996), 132 descendants of its own
- K970734: Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems (1997), 131 descendants of its own
- K992660: Urf Digital - OT (1999), 130 descendants of its own
- K062623: Axiom Luminos DRF (2007), 78 descendants of its own
- K040675: Axiom Artis U (2004), 49 descendants of its own

## Recalls of this device
- Nov 21, 2016 · Class II · Z-0914-2017: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.

Source page: https://510kreport.com/device/K924310
Methodology: https://510kreport.com/methodology