# K960865: Step Option to Prism 2000

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Sep 20, 1996 after 200 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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 no predicate by number.

## Most influential descendants
- K982300: Transview (Transmission System),Model NDTR-701A (1998), 0 descendants of its own

## Indications for use
This device is intended to be used for diagnostic imaging of organs and lesions.

Source page: https://510kreport.com/device/K960865
Methodology: https://510kreport.com/methodology