510(k) · Cleared

Recalled · Class II · 2012

Model DFP-8000D/FPD Digital Radiography System with Flat Panel Detector

K052884510(k) TraditionalCleared Oct 26, 200513-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

Toshiba America Medical Systems, In.C · OWB Interventional Fluoroscopic X-Ray System

Cleared on Oct 26, 2005 as substantially equivalent to K013608 (Toshiba America Medical Systems, In.C, 2001) after a 13-day review. Its family tree reaches back 2 generations to 1994. 57 later devices descend from it. It has been recalled 2 times.

Decided: Oct 26, 2005
Review: 13 days
Class: Class II
Product code: OWB
Recalls: 2
Predicates: 1

Its longest line of descent runs back 2 generations to K941611 (1994). 57 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK941611 TDA-4000/A4Toshiba America Medical Systems, In.C · 1994 · Recalled
1 generation backK013608 Digital Radiography System, Model DFP-8000DToshiba America Medical Systems, In.C · 2001 · Recalled
This deviceK052884 Model DFP-8000D/FPD Digital Radiography System with Flat Panel…Toshiba America Medical Systems, In.C · 2005
Descendant · cites it directly · 23 of its ownK081582 Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · Recalled
Descendant · 2 generations on · 21 of its ownK101868 Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010
Descendant · 3 generations on · 20 of its ownK120073 Infx-8000V withToshibamedical Systems Corporation · 2012 · Recalled
Descendant · cites it directly · 13 of its ownK081624 Infx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C · 2008 · Recalled
Descendant · 2 generations on · 11 of its ownK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

2008high 10 (2018) · low 0 (2009)2026

Most influential descendants

Showing 5 of 57 · See all

K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · cites it directly23descendants
K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010 · 2 generations on21descendants
K120073Infx-8000V withToshibamedical Systems Corporation · 2012 · 3 generations on20descendants
K081624Infx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C · 2008 · cites it directly13descendants
K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018 · 2 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K941611	TDA-4000/A4	Toshiba America Medical Systems, In.C	1994	1
−1	K013608	Digital Radiography System, Model DFP-8000D	Toshiba America Medical Systems, In.C	2001	2
0 (this device)	K052884	Model DFP-8000D/FPD Digital Radiography System with Flat Panel Detector	Toshiba America Medical Systems, In.C	2005	—
+1	K081582	Infx-8000V, Infinix-Cfi and Infinix Vfi	Toshiba America Medical Systems, In.C	2008	1
+2	K101868	Infinix-I Interventional Angiography System Model Infx-8000V	Toshiba America Medical Systems, In.C	2010	—
+3	K120073	Infx-8000V with	Toshibamedical Systems Corporation	2012	3
+1	K081624	Infx-8000F (Infinix Csi and Infinix Dpi)	Toshiba America Medical Systems, In.C	2008	8
+2	K173088	Vitrea Software Toshiba Package VSTP-001A	Toshibamedical Systems Corporation	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	4	0
2010	2	0
2011	2	0
2012	2	0
2013	1	0
2014	3	0
2015	5	0
2016	3	0
2017	3	0
2018	10	0
2019	2	0
2020	3	0
2021	4	0
2022	2	0
2023	2	0
2024	4	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K052884, 1994–2026Source: 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 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 18.3 · 18 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? (1)

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
*	K013608	Digital Radiography System, Model DFP-8000D Summary page 1 …ICAL SYSTEMS CORPORATION 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan Date of Submission: October 05, 2005 Predicate Device: DFP-8000D with Image Intensifier (K013608) DEVICE DESCRIPTION This equipment is a digital radiography with Flat Panel Detector (FPD) used in diagnostic X-ray angiography s…	Toshiba America Medical Systems, In.C	2001	2

Also cleared against K013608: 1 other device →

What descends from it? (57)

See all 57

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

Number	Device	Applicant	Decided	Descendants
K081582	Infx-8000V, Infinix-Cfi and Infinix Vfi	Toshiba America Medical Systems, In.C	2008	23
K081624	Infx-8000F (Infinix Csi and Infinix Dpi)	Toshiba America Medical Systems, In.C	2008	13
K081621	Infx-8000C (Infinix CC-I and VC-I)	Toshiba America Medical Systems, In.C	2008	10
K100102	CS-Series-FP	Omega Medical Imaging, Inc.	2010	8

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 8, 2012	Class II	Z-0994-2013	Software design	Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may…
Oct 1, 2007	Not classified	Z-0293-2008	Software design	System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 7.5 years on median.
2 of the 2 ancestors have a recall of any class.
Of its descendants, K081582 (Toshiba America Medical Systems, In.C, 2008) has gone furthest, with 23 descendants of its own.
1 other device also cites its predicate K013608.

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	—

What is it indicated for?

This device is a digital radiography system used in diagnostic X-ray angiography system configuration.

This X-ray angiography system is indicated for use in diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower limb blood vessels.

It is intended to replace images obtained through the image intensifier technology.

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/K052884 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052884: Model DFP-8000D/FPD Digital Radiography System with Flat Panel Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052884

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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