510(k) Report

510(k) · Cleared

Cleared

Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet (DH-1)

K934523510(k) TraditionalCleared Feb 8, 1995509-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

Radionics, Inc. · IYE Accelerator, Linear, Medical

Cleared on Feb 8, 1995 after a 509-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it.

Decided
Feb 8, 1995
Review
509 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
0

32 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 1996: 2 descendants cleared1999: 4 descendants cleared1998: 2 descendants cleared2008: 1 descendant cleared2011: 1 descendant cleared2003: 1 descendant cleared1997: 1 descendant cleared2026: 2 descendants cleared2016: 2 descendants cleared2005: 1 descendant cleared2010: 2 descendants cleared2023: 5 descendants cleared2014: 1 descendant cleared2020: 1 descendant cleared2019: 1 descendant cleared2013: 1 descendant cleared2024: 1 descendant cleared2018: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared1995200020052010201520202025
  1. This deviceK934523 Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth…Radionics, Inc. · 1995
  2. Descendant · cites it directly · 13 of its ownK960338 Stereotactic Body FrameElekta Instrument AB · 1996
  3. Descendant · 2 generations on · 9 of its ownK970291 Accessories to the Stereotactic Body FramElekta Instrument AB · 1997
  4. Descendant · 2 generations on · 8 of its ownK982463 Extracranial Radiotherapy SystemHowmedica, Inc. · 1998
  5. Descendant · cites it directly · 8 of its ownK962155 Gill-Thomas-Cosman (GTC) Dental TrayRadionics Software Applications, Inc. · 1996
  6. Descendant · 2 generations on · 7 of its ownK991336 Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco) · 1999

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

1996: 21997: 11998: 21999: 42003: 12005: 12008: 12010: 22011: 12013: 12014: 12016: 22017: 12018: 12019: 12020: 12021: 12023: 52024: 12026: 2
1996high 5 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 32 · See all
  • K960338Stereotactic Body FrameElekta Instrument AB · 1996 · cites it directly13descendants
  • K970291Accessories to the Stereotactic Body FramElekta Instrument AB · 1997 · 2 generations on9descendants
  • K982463Extracranial Radiotherapy SystemHowmedica, Inc. · 1998 · 2 generations on8descendants
  • K962155Gill-Thomas-Cosman (GTC) Dental TrayRadionics Software Applications, Inc. · 1996 · cites it directly8descendants
  • K991336Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco) · 1999 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934523Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth…Radionics, Inc.1995—
+1K960338Stereotactic Body FrameElekta Instrument AB1996—
+2K970291Accessories to the Stereotactic Body FramElekta Instrument AB1997—
+2K982463Extracranial Radiotherapy SystemHowmedica, Inc.1998—
+1K962155Gill-Thomas-Cosman (GTC) Dental TrayRadionics Software Applications, Inc.1996—
+2K991336Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco)1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199710
199820
199940
200310
200510
200810
201020
201110
201310
201410
201620
201710
201810
201910
202010
202110
202350
202410
202620
FIG. 1 — Lineage of K934523, 1995–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (32)

See all 32

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

NumberDeviceApplicantDecidedDescendants
K960338Stereotactic Body FrameElekta Instrument AB199613
K962155Gill-Thomas-Cosman (GTC) Dental TrayRadionics Software Applications, Inc.19968
K972324Leksell Stereotactic SystemElekta Instrument AB19987
K991237Xplan-2 with Head and Neck Localizer, Model HNLRadionics, Inc.19992
K081935Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp.20081
K991523TLC Pediatric Frame, Model TLC-SysRadionics, Inc.19990

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, K960338 (Elekta Instrument AB, 1996) has gone furthest, with 13 descendants 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

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—

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56 FDA decisions under this applicant name. See the company

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  • K992226XDS External CSF Drainage and Monitoring SystemRadionics, Inc. · 2000
  • K001950Optical Tracking System (Ots)Radionics, Inc. · 2000

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The IYE category page

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  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
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https://510kreport.com/device/K934523 · printed Nov 4, 2026

Cite this page

510(k) Report. “K934523: Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet (DH-1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934523

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026