510(k) · Cleared

Cleared

MAPCHECK2, Arccheck

K131466510(k) TraditionalCleared Aug 20, 201391-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

Sun Nuclear Corporation · IYE Accelerator, Linear, Medical

Cleared on Aug 20, 2013 as substantially equivalent to K935928 (Radiological Imaging Technology, Inc., 1994) after a 91-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.

Decided: Aug 20, 2013
Review: 91 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K935928 (1994). 3 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK935928 Rit 113 Film Analysis SystemRadiological Imaging Technology, Inc. · 1994
This deviceK131466 MAPCHECK2, ArccheckSun Nuclear Corporation · 2013
Descendant · cites it directly · 1 of its ownK142617 ArcCHECKSun Nuclear Corporation · 2015
Descendant · cites it directly · 0 of its ownK160405 Octavius I, Octavius II, Octavius Iii, Octavius 4DPtw-Freiburg Physikalisch-Technische-Werkstaetten · 2017 · Recalled
Descendant · cites it directly · 0 of its ownK160057 ArcCHECK-MRSun Nuclear Corporation · 2016

Most influential descendants

Showing 3 of 3 · See all

K142617ArcCHECKSun Nuclear Corporation · 2015 · cites it directly1descendant
K160405Octavius I, Octavius II, Octavius Iii, Octavius 4DPtw-Freiburg Physikalisch-Technische-Werkstaetten · 2017 · cites it directly0descendants
K160057ArcCHECK-MRSun Nuclear Corporation · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935928	Rit 113 Film Analysis System	Radiological Imaging Technology, Inc.	1994	—
0 (this device)	K131466	MAPCHECK2, Arccheck	Sun Nuclear Corporation	2013	—
+1	K142617	ArcCHECK	Sun Nuclear Corporation	2015	—
+1	K160405	Octavius I, Octavius II, Octavius Iii, Octavius 4D	Ptw-Freiburg Physikalisch-Technische-Werkstaetten	2017	2
+1	K160057	ArcCHECK-MR	Sun Nuclear Corporation	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2016	1	0
2017	1	0

FIG. 1 — Lineage of K131466, 1994–2017Source: 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

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
*	K935928	Rit 113 Film Analysis System Summary page 1 …ode: lYE Predicate Device: Model Name: RIT113 Film Analysis System Common Name: Film Scanning System 510O(k) # K935928 Manufacturer: Radiation Imaging Technology Submitted: Dec 7, 1993…	Radiological Imaging Technology, Inc.	1994	—

Also cleared against K935928: 5 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K142617	ArcCHECK	Sun Nuclear Corporation	2015	1
K160405	Octavius I, Octavius II, Octavius Iii, Octavius 4D	Ptw-Freiburg Physikalisch-Technische-Werkstaetten	2017	0
K160057	ArcCHECK-MR	Sun Nuclear Corporation	2016	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?

Its one ancestor has no recall.
Of its descendants, K142617 (Sun Nuclear Corporation, 2015) has gone furthest, with 1 descendant of its own.
5 other devices also cite its predicate K935928.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

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?

Model 1177 MapCHECK 2 is a two-dimensional (2D) radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).

ArcCHECK, Model 1220 is a three-dimensional (3D) radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K131466 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131466: MAPCHECK2, Arccheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131466

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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