510(k) · Cleared

Recalled · 2005

Philips Integris Allura 9 with FD Option

K020055510(k) TraditionalCleared Mar 15, 200266-day reviewClass II21 CFR 892.1650Recalls 2

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

Philips Medical Systems · JAA System, X-Ray, Fluoroscopic, Image-Intensified

Cleared on Mar 15, 2002 as substantially equivalent to K984545 (Philips Medical Systems North America, Inc., 1999) and 1 other predicate after a 66-day review. Its family tree reaches back 2 generations to 1989. 10 of the 130 devices in its family, counting itself, have a Class I recall. 124 later devices descend from it. It has been recalled 2 times.

Decided: Mar 15, 2002
Review: 66 days
Class: Class II
Product code: JAA
Recalls: 2
Predicates: 2

Its longest line of descent runs back 2 generations to K890348 (1989). 5 ancestors in all. 124 later devices descend from it, 2 citing it directly. 10 of the 130 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
1 generation backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
This deviceK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002
Descendant · cites it directly · 114 of its ownK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
Descendant · 2 generations on · 113 of its ownK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
Descendant · 3 generations on · 64 of its ownK041949 Allura Xper FD10Philips Medical Systems North America Co. · 2004 · Recalled
Descendant · 3 generations on · 51 of its ownK031836 Philips Fresco Release 1Philips Medical Systems North America Co. · 2003
Descendant · 4 generations on · 49 of its ownK062650 EP Navigator SoftwarePhilips Medical Systems · 2006

Showing 5 of 124 descendants. See all descendants

Descendants cleared per year

2002high 16 (2025) · low 0 (2005)2026

Class I recalls in this family

K130842 Allura Xper FD or Table Series; Allura Xper FD10…4 generations on · 2013
K190106 Intra-Operative Positioning System; Simple Curve…8 generations on · 2019
K162859 Allura Xper FD series and Allura Xper OR Table…8 generations on · 2016
K163715 Allura Xper R98 generations on · 2017

Most influential descendants

Showing 5 of 124 · See all

K022899Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · cites it directly114descendants
K031333Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · 2 generations on113descendants
K041949Allura Xper FD10Philips Medical Systems North America Co. · 2004 · 3 generations on64descendants
K031836Philips Fresco Release 1Philips Medical Systems North America Co. · 2003 · 3 generations on51descendants
K062650EP Navigator SoftwarePhilips Medical Systems · 2006 · 4 generations on49descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K890348	LC, Cardiac Positioner #B5078A	General Electric Co.	1989	5
−1	K993037	LCV+ Version 2	Ge Medical Systems, Inc.	2000	6
0 (this device)	K020055	Philips Integris Allura 9 with FD Option	Philips Medical Systems	2002	—
+1	K022899	Philips Integris Allura Flat Detector Release 1.0	Philips Medical Systems North America Co.	2002	8
+2	K031333	Philips Integris Allura Flat Detector Release 1.2	Philips Medical Systems North America, Inc.	2003	25
+3	K041949	Allura Xper FD10	Philips Medical Systems North America Co.	2004	48
+3	K031836	Philips Fresco Release 1	Philips Medical Systems North America Co.	2003	—
+4	K062650	EP Navigator Software	Philips Medical Systems	2006	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	2	0
2004	1	0
2006	1	0
2008	1	0
2009	3	0
2010	6	0
2011	2	0
2012	7	0
2013	6	1
2014	9	0
2015	2	0
2016	7	1
2017	5	2
2018	8	0
2019	4	1
2020	6	1
2021	6	0
2022	6	0
2023	6	1
2024	8	2
2025	16	1
2026	11	0

FIG. 1 — Lineage of K020055, 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.

10 devices in this family have a Class I recall. 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 JAA device

#1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

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 …y equivalent to the Philips Integris H5000 system manufactured by Philips Medical Systems. The Integris H5000 received a 510(k) substantially equivalent determination in K984545 on February 25, 1999. : The FD option is also substantially equivalent to GE Medical Systems' solid state digital detector clear…	Philips Medical Systems North America, Inc.	1999	17
*	K993037	LCV+ Version 2 Summary page 1 …ebruary 25, 1999. : The FD option is also substantially equivalent to GE Medical Systems' solid state digital detector cleared by FDA on February 14, 2000, under 510(k) K993037. Device Description: The Philips Integris Allura 9 system with FD Option is an angiographic x-ray system with a solid state x-r…	Ge Medical Systems, Inc.	2000	6

Also cleared against K984545: 7 other devices →

What descends from it? (124)

See all 124

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

Number	Device	Applicant	Decided	Descendants
K022899	Philips Integris Allura Flat Detector Release 1.0	Philips Medical Systems North America Co.	2002	114
K100102	CS-Series-FP	Omega Medical Imaging, Inc.	2010	8

Has anything in its family been recalled? (10 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 12, 2005	Not classified	Z-0206-06	Other	Potential for high voltage exposure involving the injector interface connector of patient support tables.
Oct 12, 2005	Not classified	Z-0207-06	Other	Potential for high voltage exposure involving the injector interface connector of patient support tables.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K130842Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura Xper FD Biplane…Philips Medical Systems Nederland B.V. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 111 Class I recalls
K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 8 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 8 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 8 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 9 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 9 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 9 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 9 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 10 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls

Nearest 5 of 10; all are on the web page.

What does this lineage say?

The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
3 of the 5 ancestors have a recall of any class.
Of its descendants, K022899 (Philips Medical Systems North America Co., 2002) has gone furthest, with 114 descendants of its own.
7 other devices also cite its predicate K984545.

How does its category compare?

All JAA devices

JAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAA

2in 2025

2007high 6 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAA

89in 2024

2007high 276 (2014) · low 18 (2008)2026

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

Recalls per year · JAA

4in 2025

2007high 35 (2007) · low 1 (2014)2026

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

Adverse event reports per year · JAA

33in 2025

2007high 14,000 (2011) · low 25 (2024)2025

MAUDE reports naming product code JAA, 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	1	—	35	9,517
2008	6	18	21	9,484
2009	0	—	18	12,040
2010	1	—	6	5,803
2011	4	48	7	14,000
2012	1	—	2	11,684
2013	6	129	3	13,706
2014	6	276	1	10,265
2015	3	197	1	2,922
2016	2	—	7	35
2017	1	—	3	56
2018	3	30	1	36
2019	6	49	2	49
2020	4	39	2	39
2021	6	104	2	35
2022	1	—	5	34
2023	2	—	9	41
2024	3	89	2	25
2025	2	—	4	33
2026	1	—	0	—

What is it indicated for?

The Philips Integris Allura 9 system with FD Option is intended for use in cardiac imaging applications including diagnostic, interventional procedures (such as PTCA, stent placing, atherctomies,) pacemaker implantations, and electrophysiology (EP.)

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K020055 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020055: Philips Integris Allura 9 with FD Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020055

Report an extraction error

Are you the manufacturer?

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