510(k) Report

510(k) · Cleared

Cleared

Stereotactic Head and Neck Localizer, Model 50-100

K081935510(k) TraditionalCleared Oct 7, 200892-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

Aktina Medical Physics Corp. · IYE Accelerator, Linear, Medical

Cleared on Oct 7, 2008 as substantially equivalent to K030439 (Medical Intelligence Medizintechnik GmbH, 2003) and 5 other predicates after a 92-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.

Decided
Oct 7, 2008
Review
92 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K934523 (1995). 10 ancestors in all, the oldest K934657 (1994). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2003: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestor1994: 1 other ancestor2011: 1 descendant clearedK934523 · Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet (DH-1) · Radionics, Inc. · 1995K962155 · Gill-Thomas-Cosman (GTC) Dental Tray · Radionics Software Applications, Inc. · 1996K991237 · Xplan-2 with Head and Neck Localizer, Model HNL · Radionics, Inc. · 1999 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors 1 generation forward: 1 descendant K991237 · Xplan-2 with Head and Neck Localizer, Model HNL · Radionics, Inc. · 1999 · recalledK962155 · Gill-Thomas-Cosman (GTC) Dental Tray · Radionics Software Applications, Inc. · 1996K934523 · Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet (DH-1) · Radionics, Inc. · 19950
  1. Root · 3 generations backK934523 Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth…Radionics, Inc. · 1995
  2. 2 generations backK962155 Gill-Thomas-Cosman (GTC) Dental TrayRadionics Software Applications, Inc. · 1996
  3. 1 generation backK991237 Xplan-2 with Head and Neck Localizer, Model HNLRadionics, Inc. · 1999 · Recalled
  4. This deviceK081935 Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp. · 2008
  5. Descendant · cites it directly · 0 of its ownK103616 Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp. · 2011

Most influential descendants

Showing 1 of 1 · See all
  • K103616Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K934523Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth…Radionics, Inc.1995—
−2K962155Gill-Thomas-Cosman (GTC) Dental TrayRadionics Software Applications, Inc.1996—
−1K991237Xplan-2 with Head and Neck Localizer, Model HNLRadionics, Inc.19991
0 (this device)K081935Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp.2008—
+1K103616Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199610
199710
199810
200310
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
FIG. 1 — Lineage of K081935, 1995–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K030439Headfix
Summary page 1
…e according to 21 CFR 892.5050, "Medical charged- particle radiation therapy system." The product code is YE. 3. Predicate Devices 1) VBH HeadFix, K030439, manufactured by Medical Intelligence Medizintechnik, Schwabmunchen, Germany 2) X-Plan-2…
Medical Intelligence Medizintechnik GmbH20031
*K991237Xplan-2 with Head and Neck Localizer, Model HNL
Summary page 1
…30439, manufactured by Medical Intelligence Medizintechnik, Schwabmunchen, Germany 2) X-Plan-2 and Head and Neck Localizer (HNL), K991237 and GTC Headholder, K934523, manufactured by Radionics Software Applications, Inc, Burlington, MA 3) Stereot…
Radionics, Inc.19991
*K934523Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet…
Summary page 1
…by Medical Intelligence Medizintechnik, Schwabmunchen, Germany 2) X-Plan-2 and Head and Neck Localizer (HNL), K991237 and GTC Headholder, K934523, manufactured by Radionics Software Applications, Inc, Burlington, MA 3) Stereotactic Mask System, CT/X-Ray…
Radionics, Inc.1995—
*K945903Brainlab Mask System
Summary page 1
…934523, manufactured by Radionics Software Applications, Inc, Burlington, MA 3) Stereotactic Mask System, CT/X-Ray Localizer, and Target Positioner, K945903, K954861, and K073018, BrainLAB AG, Heimstetten, Germany 2 === P…
Brainlab Med. Computersysteme GmbH1995—
*K954861Brainlab CT/X-Ray Localizer
Summary page 1
…manufactured by Radionics Software Applications, Inc, Burlington, MA 3) Stereotactic Mask System, CT/X-Ray Localizer, and Target Positioner, K945903, K954861, and K073018, BrainLAB AG, Heimstetten, Germany 2 4. Descr…
Brainlab Med. Computersysteme GmbH1996—
*K073018Stereotactic Target Positioner, Target Positioner for Leksell Headring, Stereotactic…
Summary page 1
…by Radionics Software Applications, Inc, Burlington, MA 3) Stereotactic Mask System, CT/X-Ray Localizer, and Target Positioner, K945903, K954861, and K073018, BrainLAB AG, Heimstetten, Germany 2 4. Description…
Brainlab AG20081

Also cleared against K030439: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K103616Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp.20110

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?

  • The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
  • 3 of the 10 ancestors have a recall of any class.
  • Of its descendants, K103616 (Aktina Medical Physics Corp., 2011) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K030439.

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

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

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

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
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

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

What is it indicated for?

This product is used for patients who require external beam stereotactic radiation therapy of the head and neck region or radiosurgery of the cranial region. The system provides cranial and head and neck fixation and stereotactic localization with automatic software fiducial localization. It is intended to be used during both Computed Tomography (acquisition of the imaging series used for the patient's treatment plan) and each of the patient radiation treatments.

Indications for use as stated in the FDA summary.

Also cleared against K030439

2 other devices cite the same predicate.

  • K112210FraxionMedical Intelligence Medizintechnik GmbH · 2011
  • K092083Extend Frame System, Model 1009633Elekta Instrument AB · 20091 recall

More from Aktina Medical Physics Corp.

13 FDA decisions under this applicant name. See the company

  • K103616Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp. · 2011
  • K040709Protos SoftwareAktina Medical Physics Corp. · 2004
  • K032248Precise Carbon Fiber Table Top, Model 11-999Aktina Medical Physics Corp. · 2003
  • K014081Aktina Medical Physics Radiation Therapy WedgesAktina Medical Physics Corp. · 2002
  • K003330Aktina Medical Physics Corporation Active Breathing Coordinator (Abc)Aktina Medical Physics Corp. · 2001

Recent decisions in IYE

The IYE category page

  • K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC · 2026
  • K261718EZFluence (RADEZ V2)Radformation, Inc. · 2026
  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K252937ThinkQA 3Dosisoft SA · 2026

https://510kreport.com/device/K081935 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081935: Stereotactic Head and Neck Localizer, Model 50-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081935

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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