510(k) · Cleared

Recalled · 2005

Digital Radiography System, Model DFP-8000D

K013608510(k) TraditionalCleared Nov 15, 200115-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 Nov 15, 2001 as substantially equivalent to K941611 (Toshiba America Medical Systems, In.C, 1994) after a 15-day review. Its family tree reaches back 1 generation to 1994. 59 later devices descend from it. It has been recalled 2 times.

Decided: Nov 15, 2001
Review: 15 days
Class: Class II
Product code: OWB
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K941611 (1994). 59 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK941611 TDA-4000/A4Toshiba America Medical Systems, In.C · 1994 · Recalled
This deviceK013608 Digital Radiography System, Model DFP-8000DToshiba America Medical Systems, In.C · 2001
Descendant · cites it directly · 57 of its ownK052884 Model DFP-8000D/FPD Digital Radiography System with Flat Panel…Toshiba America Medical Systems, In.C · 2005 · Recalled
Descendant · 2 generations on · 23 of its ownK081582 Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · Recalled
Descendant · 3 generations on · 21 of its ownK101868 Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010
Descendant · 4 generations on · 20 of its ownK120073 Infx-8000V withToshibamedical Systems Corporation · 2012 · Recalled
Descendant · 2 generations on · 13 of its ownK081624 Infx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C · 2008 · Recalled

Showing 5 of 59 descendants. See all descendants

Descendants cleared per year

2004high 10 (2018) · low 0 (2006)2026

Most influential descendants

Showing 5 of 59 · See all

K052884Model DFP-8000D/FPD Digital Radiography System with Flat Panel DetectorToshiba America Medical Systems, In.C · 2005 · cites it directly57descendants
K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · 2 generations on23descendants
K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010 · 3 generations on21descendants
K120073Infx-8000V withToshibamedical Systems Corporation · 2012 · 4 generations on20descendants
K081624Infx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C · 2008 · 2 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941611	TDA-4000/A4	Toshiba America Medical Systems, In.C	1994	1
0 (this device)	K013608	Digital Radiography System, Model DFP-8000D	Toshiba America Medical Systems, In.C	2001	—
+1	K052884	Model DFP-8000D/FPD Digital Radiography System with Flat Panel Detector	Toshiba America Medical Systems, In.C	2005	2
+2	K081582	Infx-8000V, Infinix-Cfi and Infinix Vfi	Toshiba America Medical Systems, In.C	2008	1
+3	K101868	Infinix-I Interventional Angiography System Model Infx-8000V	Toshiba America Medical Systems, In.C	2010	—
+4	K120073	Infx-8000V with	Toshibamedical Systems Corporation	2012	3
+2	K081624	Infx-8000F (Infinix Csi and Infinix Dpi)	Toshiba America Medical Systems, In.C	2008	8

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
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 K013608, 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

Get a 510(k) Report

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
*	K941611	TDA-4000/A4 Summary page 1 …mage Intensified Fluoroscopic X-Ray System (Accessory) Common Name: Image Processor [Fed. Reg. No. 892.1650, Product Code: JAA] \| Predicate Device: Toshiba DFP-2000A/A4 (K941611) Description of this Device: The Digital Radiography System, Model DFP-8000D is a Digital Radiography Processor used in diagnost…	Toshiba America Medical Systems, In.C	1994	1

What descends from it? (59)

See all 59

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

Number	Device	Applicant	Decided	Descendants
K052884	Model DFP-8000D/FPD Digital Radiography System with Flat Panel Detector	Toshiba America Medical Systems, In.C	2005	57
K041027	Digital Radiography System with Flat Panel Detector, Model DFP8000D	Toshibamedical Systems Corporation	2004	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 15, 2005	Not classified	Z-0532-06	Other	In certain conditions the FOV of the lateral plane does not coincide with the X-ray exposed area, and consequently a part of the X-ray field may not be displayed in the magnification mode.
Jun 18, 2004	Not classified	Z-1337-04	Other	Defect in the mirroring unit.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K052884 (Toshiba America Medical Systems, In.C, 2005) has gone furthest, with 57 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	—

What is it indicated for?

The Digital Radiography System, Model DFP-8000D is a Digital Radiography Processor used in diagnostic X-ray angiography systems. This system processes, displays, and records digital images obtained from the detectors of X-ray TV systems (such as CCD cameras), and replays the recorded images for image diagnosis. This system is intended for use in diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels, and lower limb blood vessels.

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/K013608 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013608: Digital Radiography System, Model DFP-8000D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013608

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026