510(k) · Cleared

Cleared

Versaboard, Model 7040

K030051510(k) TraditionalCleared Apr 4, 200388-day reviewClass II21 CFR 892.5050

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

Bionix Development Corp. · IYE Accelerator, Linear, Medical

Cleared on Apr 4, 2003 as substantially equivalent to K933227 (Medtec, Inc., 1994) and 2 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1991. 18 later devices descend from it.

Decided: Apr 4, 2003
Review: 88 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K905007 (1991). 3 ancestors in all. 18 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK905007 Standard Breast Boards; Deluxe Breast BoardBionix Development Corp. · 1991
This deviceK030051 Versaboard, Model 7040Bionix Development Corp. · 2003
Descendant · cites it directly · 17 of its ownK060737 Sinmed Positioning DevicesSinmed BV · 2006
Descendant · 2 generations on · 14 of its ownK093738 Mri Patient Positioning DevicesMedtec, Inc. · 2010
Descendant · 3 generations on · 13 of its ownK111340 Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011
Descendant · 2 generations on · 7 of its ownK142420 Patient Positioning DevicesMacromedics BV · 2015
Descendant · cites it directly · 5 of its ownK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2006high 2 (2010) · low 0 (2007)2026

Most influential descendants

Showing 5 of 18 · See all

K060737Sinmed Positioning DevicesSinmed BV · 2006 · cites it directly17descendants
K093738Mri Patient Positioning DevicesMedtec, Inc. · 2010 · 2 generations on14descendants
K111340Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011 · 3 generations on13descendants
K142420Patient Positioning DevicesMacromedics BV · 2015 · 2 generations on7descendants
K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013 · cites it directly5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K905007	Standard Breast Boards; Deluxe Breast Board	Bionix Development Corp.	1991	—
0 (this device)	K030051	Versaboard, Model 7040	Bionix Development Corp.	2003	—
+1	K060737	Sinmed Positioning Devices	Sinmed BV	2006	—
+2	K093738	Mri Patient Positioning Devices	Medtec, Inc.	2010	—
+3	K111340	Head and Neck Immobilization System, Body Immobilization System	Medtec, Inc.	2011	—
+2	K142420	Patient Positioning Devices	Macromedics BV	2015	—
+1	K122888	CDR Systems Precision Patient Positioning System	Cdr Systems, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2010	2	0
2011	1	0
2012	1	0
2013	2	0
2015	1	0
2016	1	0
2017	1	0
2018	1	0
2020	1	0
2021	1	0
2022	2	0
2023	2	0
2025	1	0

FIG. 1 — Lineage of K030051, 1991–2025Source: 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 IYE? 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 IYE device

#1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 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? (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
*	K933227	Uni-Frame Head Immobilization System Summary page 1 …e City, Iowa. This device has been classified as a Class I1 device by the FDA, and has been granted marketing clearance and has been assigned the document control number K933227. The S-Type Baseplate from Med-Tec consists of a flat “board” comprised of a composite material with a carbon fibedepoxy skin an…	Medtec, Inc.	1994	2
*	K974703	Carbon Fiber Breast Board Summary page 3 …from carbon fiber/epoxy/foam core composites. Two such devices are the Carbon Fiber Breast Board manufactured and legally sold by Med- Tec, Inc. of Orange City, Iowa (K974703), and the Max 2 Deluxe TorsoBoard manufactured and legally sold by Bionix Development Corp., Toledo, Ohio (K905007). Both the C…	Medtec, Inc.	1998	—
*	K905007	Standard Breast Boards; Deluxe Breast Board Summary page 3 …legally sold by Med- Tec, Inc. of Orange City, Iowa (K974703), and the Max 2 Deluxe TorsoBoard manufactured and legally sold by Bionix Development Corp., Toledo, Ohio (K905007). Both the Carbon Fiber Breast Board from Med-Tec and the Max 2 Deluxe TorsoBoard from Bionix are intended to be used to accura…	Bionix Development Corp.	1991	—

Also cleared against K933227: 3 other devices →

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K060737	Sinmed Positioning Devices	Sinmed BV	2006	17
K122888	CDR Systems Precision Patient Positioning System	Cdr Systems, Inc.	2013	5

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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K060737 (Sinmed BV, 2006) has gone furthest, with 17 descendants of its own.
3 other devices also cite its predicate K933227.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007high 239 (2024) · low 44 (2007)2026

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

Recalls per year · IYE

1in 2025

2007high 78 (2007) · low 1 (2024)2026

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

Adverse event reports per year · IYE

101in 2025

2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, 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	23	44	78	155
2008	14	69	49	114
2009	20	63	22	174
2010	23	74	27	246
2011	11	94	73	280
2012	28	106	20	128
2013	18	88	11	96
2014	20	100	14	124
2015	20	108	8	100
2016	21	97	7	97
2017	23	94	7	125
2018	21	58	7	85
2019	19	83	2	91
2020	20	67	4	74
2021	19	86	5	68
2022	12	172	3	66
2023	18	129	7	128
2024	9	239	1	81
2025	12	170	1	101
2026	14	120	4	—

What is it indicated for?

The VersaBoard patient positioning system developed and manufactured by Bionix Development Corporation, Toledo, Ohio, is intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.

It is intended to be used by or under the direction of a licensed physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030051 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030051: Versaboard, Model 7040.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030051

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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