510(k) · Cleared

Recalled · Class II · 2013

Stereotactic Target Positioner, Target Positioner for Leksell Headring, Stereotactic Counterweight

K073018510(k) TraditionalCleared Jan 23, 200890-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

Brainlab AG · IYE Accelerator, Linear, Medical

Cleared on Jan 23, 2008 as substantially equivalent to K934657 (Brainlab Med. Computersysteme GmbH, 1994) after a 90-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it. It has been recalled once.

Decided: Jan 23, 2008
Review: 90 days
Class: Class II
Product code: IYE
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K934657 (1994). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK934657 Brainlab Linac HardwareBrainlab Med. Computersysteme GmbH · 1994
This deviceK073018 Stereotactic Target Positioner, Target Positioner for Leksell…Brainlab AG · 2008
Descendant · cites it directly · 1 of its ownK081935 Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp. · 2008
Descendant · 2 generations on · 0 of its ownK103616 Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp. · 2011

Most influential descendants

Showing 2 of 2 · See all

K081935Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp. · 2008 · cites it directly1descendant
K103616Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp. · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934657	Brainlab Linac Hardware	Brainlab Med. Computersysteme GmbH	1994	—
0 (this device)	K073018	Stereotactic Target Positioner, Target Positioner for Leksell Headring…	Brainlab AG	2008	—
+1	K081935	Stereotactic Head and Neck Localizer, Model 50-100	Aktina Medical Physics Corp.	2008	—
+2	K103616	Pinpoint Stereotactic Head and Neck Localizer	Aktina Medical Physics Corp.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	1	0

FIG. 1 — Lineage of K073018, 1994–2011Source: 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? (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
*	K934657	Brainlab Linac Hardware Summary page 1 …Headring, Stereotactic Counterweight Common Name: Target Positioner, Counterweight Predicate Device: BrainLAB LINAC Hardware (K934657) Device Classification Name: Medical charged-particle radiation therapy system (89bZ050) Regulatory Class: Glass II Intended Us…	Brainlab Med. Computersysteme GmbH	1994	—

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
K081935	Stereotactic Head and Neck Localizer, Model 50-100	Aktina Medical Physics Corp.	2008	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 16, 2013	Class II	Z-2083-2013	Device Design	The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K081935 (Aktina Medical Physics Corp., 2008) 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. 2008, 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?

The Target Positioner (TaPo) is used to position the patient for the stereotactic radiotherapy/radiosurgery.

The optional usage of the Stereotactic Counterweight improves the accuracy of patient positioning during the treatment by compensating the weight of the Target Positioner after its removal.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073018 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073018: Stereotactic Target Positioner, Target Positioner for Leksell Headring, Stereotactic Counterweight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073018

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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