# K031836: Philips Fresco Release 1

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America Co.
- Decided: Aug 14, 2003 after 62 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: 5 generations back to K890348 (1989). 9 ancestors in all.
51 later devices descend from it; 3 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984545: Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) Systems, Philips Medical Systems North America, Inc. (1999) Summary page 1.
- K002016: Philips Integris Allura, Philips Medical Systems North America, Inc. (2000) Summary page 1.
- K031333: Philips Integris Allura Flat Detector Release 1.2, Philips Medical Systems North America, Inc. (2003) Summary page 1.

## Most influential descendants
- K062650: EP Navigator Software (2006), 49 descendants of its own
- K101311: EP Navigator R3 (2010), 41 descendants of its own
- K111245: Heartnavigator Release 1 (2011), 39 descendants of its own
- K121781: Echonavigator Release 1 (2012), 32 descendants of its own
- K172607: Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (2017), 28 descendants of its own

## Indications for use
The Philips Fresco release 1, option to Philips Integris Allura systems, is intended for use in a cardiovascular and vascular x-ray interventional application, viz. stent placing.

Source page: https://510kreport.com/device/K031836
Methodology: https://510kreport.com/methodology