510(k) · Cleared

Cleared

Philips Dci-SX

K921219510(k) TraditionalCleared Apr 29, 1994777-day reviewClass II21 CFR 892.1650

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

Philips Medical Systems, Inc. · OWB Interventional Fluoroscopic X-Ray System

Cleared on Apr 29, 1994 after a 777-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 76 later devices descend from it.

Decided: Apr 29, 1994
Review: 777 days
Class: Class II
Product code: OWB
Recalls: None
Predicates: 0

76 later devices descend from it, 2 citing it directly.

This deviceK921219 Philips Dci-SXPhilips Medical Systems, Inc. · 1994
Descendant · cites it directly · 74 of its ownK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
Descendant · 2 generations on · 48 of its ownK022292 Impax Diagnostic Display Station,Impax Clinical Review Station,Impax…Agfa Corp. · 2002 · Recalled
Descendant · 2 generations on · 19 of its ownK031350 3TP Software Option3tp, LLC · 2003 · Recalled
Descendant · 2 generations on · 17 of its ownK041286 Dynacad V1.0Mri Devices Corp. · 2004
Descendant · 3 generations on · 14 of its ownK061421 Erad PacsErad, Inc. · 2006

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

1997high 6 (2005) · low 0 (1999)2026

Most influential descendants

Showing 5 of 76 · See all

K971965Philips EasyvisionPhilips Medical Systems, Inc. · 1998 · cites it directly74descendants
K022292Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology…Agfa Corp. · 2002 · 2 generations on48descendants
K0313503TP Software Option3tp, LLC · 2003 · 2 generations on19descendants
K041286Dynacad V1.0Mri Devices Corp. · 2004 · 2 generations on17descendants
K061421Erad PacsErad, Inc. · 2006 · 3 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K921219	Philips Dci-SX	Philips Medical Systems, Inc.	1994	—
+1	K971965	Philips Easyvision	Philips Medical Systems, Inc.	1998	—
+2	K022292	Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for…	Agfa Corp.	2002	9
+2	K031350	3TP Software Option	3tp, LLC	2003	1
+2	K041286	Dynacad V1.0	Mri Devices Corp.	2004	—
+3	K061421	Erad Pacs	Erad, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	2	0
2002	1	0
2003	5	0
2004	4	0
2005	6	0
2006	3	0
2007	1	0
2008	1	0
2009	4	0
2010	1	0
2011	2	0
2012	5	0
2013	1	0
2014	4	0
2015	3	0
2016	2	0
2017	3	0
2018	4	0
2019	3	0
2020	3	0
2021	2	0
2022	1	0
2023	3	0
2024	6	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K921219, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in OWB? 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 OWB device

#1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.2 · 18 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (76)

See all 76

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

Number	Device	Applicant	Decided	Descendants
K971965	Philips Easyvision	Philips Medical Systems, Inc.	1998	74
K972103	Philips Easyvision	Philips Medical Systems North America, Inc.	1997	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?

Of its descendants, K971965 (Philips Medical Systems, Inc., 1998) has gone furthest, with 74 descendants of its own.

How does its category compare?

All OWB devices

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

FDA decisions per year · OWB

22in 2025

2007high 24 (2021) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OWB

148in 2025

2007high 221 (2026) · low 37 (2012)2026

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

Recalls per year · OWB

42so far in 2026, the most since 2007

2007high 42 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OWB

14,008in 2025

2007high 14,008 (2025) · low 0 (2008)2025

MAUDE reports naming product code OWB, 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	3	52	0	1
2008	4	135	1	0
2009	9	99	0	0
2010	7	66	0	0
2011	6	79	0	1
2012	6	37	0	1
2013	11	119	10	27
2014	15	158	9	103
2015	11	66	35	2,134
2016	16	103	13	4,074
2017	20	76	13	1,604
2018	23	54	6	1,449
2019	9	174	7	1,558
2020	16	53	8	1,581
2021	24	60	31	1,981
2022	21	90	24	2,932
2023	12	152	22	7,604
2024	13	126	11	7,942
2025	22	148	30	14,008
2026	15	221	42	—

https://510kreport.com/device/K921219 · printed Nov 6, 2026

Cite this page

510(k) Report. “K921219: Philips Dci-SX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921219

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026