# K972103: Philips Easyvision

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Sep 2, 1997 after 90 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: 2 generations back to K913770 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921219: Philips Dci-SX, Philips Medical Systems, Inc. (1994) Summary page 1.
- K960613: GE Advantage Windows Review Workstation, GE Medical Systems (1996) Summary page 1.
- K942120: Advantage Windows Diagnostic X-Ray Workstation, GE Medical Systems (1994) Summary page 1.
- K913770: Advantage V.S. CT/MR Rad Diagnostic Workstation, General Electric Co. (1991) Summary page 1.
- K920578: Philips Gyroscan T5 Series II, Philips Medical Systems North America, Inc. (1992) Summary page 1.
- K920791: Gyroscan S15/Acs-II, Philips Medical Systems, Inc. (1992) Summary page 1.

## Indications for use
The MR Cardiac Analysis Package is indicated for use in association with cardiac and cardiovascular examinations where it is useful or necessary to perform qualitative or quantitative analysis.

Source page: https://510kreport.com/device/K972103
Methodology: https://510kreport.com/methodology