510(k) · Cleared

Recalled · Class II · 2014

Alignrt

K052682510(k) TraditionalCleared Jan 6, 2006100-day reviewClass II21 CFR 892.5050Recalls 1

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

Vision RT Limited · IYE Accelerator, Linear, Medical

Cleared on Jan 6, 2006 as substantially equivalent to K983660 (Brainlab, Inc., 1999) and 1 other predicate after a 100-day review. Its family tree reaches back 1 generation to 1999. 18 later devices descend from it. It has been recalled once.

Decided: Jan 6, 2006
Review: 100 days
Class: Class II
Product code: IYE
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K981153 (1999). 2 ancestors in all. 18 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK981153 OsirisHuestis Medical · 1999
This deviceK052682 AlignrtVision RT Limited · 2006
Descendant · cites it directly · 12 of its ownK072171 Gatect-RTVision RT Limited · 2007
Descendant · cites it directly · 8 of its ownK123371 Alignrt PlusVision RT Limited · 2013 · Recalled
Descendant · 2 generations on · 7 of its ownK181218 AlignRT PlusVision Rt, Ltd. · 2018
Descendant · 3 generations on · 6 of its ownK193431 AlignRT PlusVision Rt, Ltd. · 2020
Descendant · 4 generations on · 5 of its ownK203387 AlignRT PlusVision Rt, Ltd. · 2021

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2007high 3 (2020) · low 0 (2008)2026

Most influential descendants

Showing 5 of 18 · See all

K072171Gatect-RTVision RT Limited · 2007 · cites it directly12descendants
K123371Alignrt PlusVision RT Limited · 2013 · cites it directly8descendants
K181218AlignRT PlusVision Rt, Ltd. · 2018 · 2 generations on7descendants
K193431AlignRT PlusVision Rt, Ltd. · 2020 · 3 generations on6descendants
K203387AlignRT PlusVision Rt, Ltd. · 2021 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K981153	Osiris	Huestis Medical	1999	—
0 (this device)	K052682	Alignrt	Vision RT Limited	2006	—
+1	K072171	Gatect-RT	Vision RT Limited	2007	—
+1	K123371	Alignrt Plus	Vision RT Limited	2013	5
+2	K181218	AlignRT Plus	Vision Rt, Ltd.	2018	—
+3	K193431	AlignRT Plus	Vision Rt, Ltd.	2020	—
+4	K203387	AlignRT Plus	Vision Rt, Ltd.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2009	1	0
2012	2	0
2013	1	0
2018	2	0
2020	3	0
2021	2	0
2024	2	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K052682, 1999–2026Source: 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 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? (2)

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
*	K983660	Exactrac (Brainlab Patient Positioning System) Summary page 1 …Classification Name System, radiation therapy, charged-particle Product code: LHN Regulation: 21 CFR 892.5050 4 Predicate Devices Exactrac system (K983660) and, Osiris system (K981153) 5 Device Description AlIgnRT is a video-based three-dimensional (3D) surface imaging sy…	Brainlab, Inc.	1999	—
*	K981153	Osiris Summary page 1 …, radiation therapy, charged-particle Product code: LHN Regulation: 21 CFR 892.5050 4 Predicate Devices Exactrac system (K983660) and, Osiris system (K981153) 5 Device Description AlIgnRT is a video-based three-dimensional (3D) surface imaging system, which is used to image…	Huestis Medical	1999	—

Also cleared against K983660: 2 other devices →

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K072171	Gatect-RT	Vision RT Limited	2007	12
K123371	Alignrt Plus	Vision RT Limited	2013	8
K082582	Sentinel, Model SP-001	C-Rad Positioning AB	2009	5
K173926	DORADOnova MR3T	Lap GmbH Laser Applikationen	2018	0
K063839	Positioner	C-Rad Positioning AB	2007	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 11, 2014	Class II	Z-0934-2015	Under Investigation by firm	Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K072171 (Vision RT Limited, 2007) has gone furthest, with 12 descendants of its own.
2 other devices also cite its predicate K983660.

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 AlignRT system is used to position patients undergoing external beam radiation therapy. Prior to each treatment session the patient is registered to the position which best reproduces the patient's position during treatment simulation. The system can also monitor the patient's position during treatment so that movements from the optimum position can be detected. Patient contour data can be extracted and exported from the acquired data for the purpose of treatment planning by radiotherapy professionals. AlignRT is used by radiotherapy professionals in appropriate hospital environments. It can be used with all types of radiotherapy patients and can image any visible anatomical region.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052682 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052682: Alignrt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052682

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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