510(k) · Cleared

Cleared

Philips Fresco Release 1

K031836510(k) TraditionalCleared Aug 14, 200362-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Philips Medical Systems North America Co. · LLZ System, Image Processing, Radiological

Cleared on Aug 14, 2003 as substantially equivalent to K984545 (Philips Medical Systems North America, Inc., 1999) and 2 other predicates after a 62-day review. Its family tree reaches back 5 generations to 1989. 51 later devices descend from it.

Decided: Aug 14, 2003
Review: 62 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K890348 (1989). 9 ancestors in all. 51 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 5 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
4 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
3 generations backK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
2 generations backK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
1 generation backK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
This deviceK031836 Philips Fresco Release 1Philips Medical Systems North America Co. · 2003
Descendant · cites it directly · 49 of its ownK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
Descendant · 2 generations on · 41 of its ownK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
Descendant · 3 generations on · 39 of its ownK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
Descendant · 4 generations on · 32 of its ownK121781 Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012
Descendant · 5 generations on · 28 of its ownK172607 Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic…Philips Health Care · 2017 · Recalled

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2006high 9 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 51 · See all

K062650EP Navigator SoftwarePhilips Medical Systems · 2006 · cites it directly49descendants
K101311EP Navigator R3Philips Medical Systems North America Co. · 2010 · 2 generations on41descendants
K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011 · 3 generations on39descendants
K121781Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012 · 4 generations on32descendants
K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care · 2017 · 5 generations on28descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K890348	LC, Cardiac Positioner #B5078A	General Electric Co.	1989	5
−4	K993037	LCV+ Version 2	Ge Medical Systems, Inc.	2000	6
−3	K020055	Philips Integris Allura 9 with FD Option	Philips Medical Systems	2002	2
−2	K022899	Philips Integris Allura Flat Detector Release 1.0	Philips Medical Systems North America Co.	2002	8
−1	K031333	Philips Integris Allura Flat Detector Release 1.2	Philips Medical Systems North America, Inc.	2003	25
0 (this device)	K031836	Philips Fresco Release 1	Philips Medical Systems North America Co.	2003	—
+1	K062650	EP Navigator Software	Philips Medical Systems	2006	—
+2	K101311	EP Navigator R3	Philips Medical Systems North America Co.	2010	—
+3	K111245	Heartnavigator Release 1	Philips Medical Systems Nederland B.V.	2011	—
+4	K121781	Echonavigator Release 1	Philips Medical Systems Nederland B.V.	2012	—
+5	K172607	Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound…	Philips Health Care	2017	31

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1995	1	0
1999	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2009	1	0
2010	1	0
2011	1	0
2012	1	0
2013	1	0
2014	4	0
2017	2	0
2018	4	0
2020	4	0
2021	2	0
2022	5	0
2023	3	0
2024	5	0
2025	9	0
2026	7	0

FIG. 1 — Lineage of K031836, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K984545	Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) Systems Summary page 1 …elease 1 Classification Name: Image processing system, Class I I , LLZl, 892.2050 Predicate Device: The Philips diagnostic X-ray systems Integris H5000 (K984545), lntegris Allura (K002016) and the Integris Allura Flat Detector (K031333) systems have the ability to visualize the stent. (bas…	Philips Medical Systems North America, Inc.	1999	17
*	K002016	Philips Integris Allura Summary page 1 …me: Image processing system, Class I I , LLZl, 892.2050 Predicate Device: The Philips diagnostic X-ray systems Integris H5000 (K984545), lntegris Allura (K002016) and the Integris Allura Flat Detector (K031333) systems have the ability to visualize the stent. (basic stent visibility). Phili…	Philips Medical Systems North America, Inc.	2000	13
*	K031333	Philips Integris Allura Flat Detector Release 1.2 Summary page 1 …, LLZl, 892.2050 Predicate Device: The Philips diagnostic X-ray systems Integris H5000 (K984545), lntegris Allura (K002016) and the Integris Allura Flat Detector (K031333) systems have the ability to visualize the stent. (basic stent visibility). Philips Fresco release 1, as an add-on to these syste…	Philips Medical Systems North America, Inc.	2003	25

Also cleared against K984545: 7 other devices →

What descends from it? (51)

See all 51

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062650	EP Navigator Software	Philips Medical Systems	2006	49
K121296	Interventional Workspot	Philips Medical Systems Nederland B.V.	2013	1
K092004	GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQ	GE Healthcare	2009	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 8 months on median.
7 of the 9 ancestors have a recall of any class.
Of its descendants, K062650 (Philips Medical Systems, 2006) has gone furthest, with 49 descendants of its own.
7 other devices also cite its predicate K984545.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031836 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031836: Philips Fresco Release 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031836

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026