# K963624: Philips Sli Series Linear Accelerator

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Dec 6, 1996 after 86 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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.
90 later devices descend from it; 4 cite it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Philips SL Series Linear Accelerators: named in the summary without a submission number
- (no number) Philips MLC products: named in the summary without a submission number

## Most influential descendants
- K032996: Elekta Synergy System (2003), 85 descendants of its own
- K040192: ON-Board Imager Device (2004), 79 descendants of its own
- K042720: ON-Board Imager Device (2004), 76 descendants of its own
- K092871: Trilogy MX (2009), 61 descendants of its own
- K111106: Truebeam (2011), 43 descendants of its own

## Recalls of this device
- May 28, 2013 · Class II · Z-1064-2014: Customers are resetting the default values outside recommended factory settings.
- May 6, 2011 · Not classified · Z-3079-2011: A small number of the Modular Reverse Diodes (D1A), a component in the equipment room of the Elekta Linear Accelerator, have ruptured.

Source page: https://510kreport.com/device/K963624
Methodology: https://510kreport.com/methodology