# K982010: FACTS

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Nov 19, 1998 after 164 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K800639 (1980). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955268: PQ-2000+ Computed Tomography X-Ray System, Philips Medical Systems (Cleveland), Inc. (1996) Summary page 2.
- K981267: Facts Monoblock, Dynarad Corp. (1998) Summary page 2.
- K800639: Orbitor, Philips Medical Systems (Cleveland), Inc. (1980) Summary page 2.

## Indications for use
The FACTS is Intended to produce routine cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axlal plane takep at different angles of the entire human body. In addition, this device's fluoroscopic mode is intended to be used in CT interventional procedures and allows some minimally invasive surgical procedures to be implemented with the CT §ystem. Procedures possible with this equipment include tumor biopsies, abscess drainage’s, bone Intervention, visceral, neck trauma evaluation and catheter placement for organ assessment.

Source page: https://510kreport.com/device/K982010
Methodology: https://510kreport.com/methodology