# K983821: Philips Inturis Cardio Image Viewing Package

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Dec 11, 1998 after 43 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K945460 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945460: Philips CD Medical Recorder, View Station, Dup[[Lication Station, Philips Medical Systems North America, Inc. (1995) Summary page 1.

## Indications for use
The PHILIPS Inturis Cardio Image Viewing Package is intended for use in processing and viewing cardiac or cardiovascular images, resulting in quantitative and/or qualitative data that can be used to estimate cardiac or cardiovascular function.

Source page: https://510kreport.com/device/K983821
Methodology: https://510kreport.com/methodology