510(k) · Cleared

Cleared

Accufix Radiolucent Pelvis and Belly Boards, Accufix Cantilever Head Board with Shoulder Depression, Accufix Radiolucent

K032156510(k) TraditionalCleared Sep 2, 200350-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

Wfr/Aquaplast Corp. · IYE Accelerator, Linear, Medical

Cleared on Sep 2, 2003 after a 50-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Sep 2, 2003
Review: 50 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK032156 Accufix Radiolucent Pelvis and Belly Boards, Accufix Cantilever Head…Wfr/Aquaplast Corp. · 2003
Descendant · cites it directly · 1 of its ownK152321 kVue Encompass SRS Insert (Encompass Insert), Encompass SRS…Qfix · 2015
Descendant · 2 generations on · 0 of its ownK182189 Encompass SRS Headframe ; Encompass MR SRS HeadframeQfix · 2018

Most influential descendants

Showing 2 of 2 · See all

K152321kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass…Qfix · 2015 · cites it directly1descendant
K182189Encompass SRS Headframe ; Encompass MR SRS HeadframeQfix · 2018 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K032156	Accufix Radiolucent Pelvis and Belly Boards, Accufix Cantilever Head Board…	Wfr/Aquaplast Corp.	2003	—
+1	K152321	kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone…	Qfix	2015	—
+2	K182189	Encompass SRS Headframe ; Encompass MR SRS Headframe	Qfix	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2018	1	0

FIG. 1 — Lineage of K032156, 2003–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K152321	kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass…	Qfix	2015	1

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, K152321 (Qfix, 2015) has gone furthest, with 1 descendant of its own.

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?

Read the full statement (139 words)

The AccuFix Radiolucent Patient Immobilization System is designed to be used with an Aquaplast RT Thermoplastic (K 935067) mold or mask to immobilize, position and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Immobilization Board attaches or mounts to a treatment table or to a Qfix Radiolucent Replacement Couchtop, which in turn mounts to the treatment table. The patient is then positioned on the immobilization board as deemed appropriate by the treating physician. Warm Aquaplast RT Thermoplastic, in its pliable state, is then molded over the patient where it conforms to the patient’s anatomy. As the Aquaplast RT Thermoplastic cools, it becomes rigid, creating a negative mold or mask of the patient’s anatomy. This mold or mask can then be used to minimize patient movement, and accu reposition the patient for subsequent treatment sessions.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K032156 · printed Nov 3, 2026

Cite this page

510(k) Report. “K032156: Accufix Radiolucent Pelvis and Belly Boards, Accufix Cantilever Head Board with Shoulder Depression, Accufix Radiolucent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032156

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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