510(k) · Cleared
ClearedGill-Thomas-Cosman (GTC) Dental Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics Software Applications, Inc. · IYE Accelerator, Linear, Medical
Cleared on Aug 22, 1996 as substantially equivalent to K934523 (Radionics, Inc., 1995) after a 79-day review. Its family tree reaches back 1 generation to 1995. 8 later devices descend from it.
- Decided
- Aug 22, 1996
- Review
- 79 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934523 (1995). 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK934523 Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth…Radionics, Inc. · 1995
- This deviceK962155 Gill-Thomas-Cosman (GTC) Dental TrayRadionics Software Applications, Inc. · 1996
- Descendant · cites it directly · 4 of its ownK153270 TruGuard Custom Tongue and Jaw PositionerBionix Development Corp. · 2016
- Descendant · 2 generations on · 2 of its ownK183374 GrayDuck StentPoll Medical, LLC · 2019
- Descendant · cites it directly · 2 of its ownK991237 Xplan-2 with Head and Neck Localizer, Model HNLRadionics, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 1 of its ownK081935 Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp. · 2008
- Descendant · 3 generations on · 0 of its ownK232293 kallisio stentra™ oral stentKallisio, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K153270TruGuard Custom Tongue and Jaw PositionerBionix Development Corp. · 2016 · cites it directly4descendants
- K183374GrayDuck StentPoll Medical, LLC · 2019 · 2 generations on2descendants
- K991237Xplan-2 with Head and Neck Localizer, Model HNLRadionics, Inc. · 1999 · cites it directly2descendants
- K081935Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp. · 2008 · 2 generations on1descendant
- K232293kallisio stentra™ oral stentKallisio, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934523 | Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth… | Radionics, Inc. | 1995 | — |
| 0 (this device) | K962155 | Gill-Thomas-Cosman (GTC) Dental Tray | Radionics Software Applications, Inc. | 1996 | — |
| +1 | K153270 | TruGuard Custom Tongue and Jaw Positioner | Bionix Development Corp. | 2016 | — |
| +2 | K183374 | GrayDuck Stent | Poll Medical, LLC | 2019 | — |
| +1 | K991237 | Xplan-2 with Head and Neck Localizer, Model HNL | Radionics, Inc. | 1999 | 1 |
| +2 | K081935 | Stereotactic Head and Neck Localizer, Model 50-100 | Aktina Medical Physics Corp. | 2008 | — |
| +3 | K232293 | kallisio stentra™ oral stent | Kallisio, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K934523 | Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet…Summary page 2…ocation, e.g., for multiple lower dose fractionated stereotactic radiotherapy treatments. Pental Tray included in the Gill-Thomas- Cosman Relocatable Head Holder System K934523 Radionics Software Applications 22 Terry Avenue Burlington, MA 01803 (617) 272-1233 Amy LaForte, Ph.D. June 3, 1996 A-2 ===… | 1995 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 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 Dental Tray holds an impression of the upper teeth, and is part of the GTC Relocatable Head Holder in stereotactic collimated beam, computer planned, LINAC (linear accelerator) based treatment. The Dental Tray holds the dental impression. The dental impression allows repeat positioning of the stereotactic frame at the same location, e.g., for multiple lower dose fractionated stereotactic radiotherapy treatments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962155 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962155: Gill-Thomas-Cosman (GTC) Dental Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962155
Report an extraction error
Are you the manufacturer?
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