← Product Code [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE) · K962155 # GILL-THOMAS-COSMAN(GTC) DENTAL TRAY (K962155) _Radionics Software Applications, Inc. · IYE · Aug 22, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K962155 ## Device Facts - **Applicant:** Radionics Software Applications, Inc. - **Product Code:** [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE.md) - **Decision Date:** Aug 22, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.5050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Therapeutic ## Indications for Use 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. ## Device Story Device: GTC Dental Tray; component of GTC Relocatable Head Holder system. Input: dental impression of patient's upper teeth. Function: secures dental impression to stereotactic frame; enables precise, repeatable patient positioning for multiple fractionated LINAC-based stereotactic radiotherapy treatments. Usage: clinical setting; operated by medical staff/physicians. Benefit: ensures accurate frame relocation across multiple treatment sessions; facilitates consistent dose delivery. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Mechanical dental tray; modified material composition compared to predicate. Used as a physical interface for stereotactic frame positioning. ## Regulatory Identification A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories. ## Predicate Devices - Dental Tray included in the Gill-Thomas-Cosman Relocatable Head Holder System ([K934523](/device/K934523.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} AUG 22 1996 K962155 ## Appendix A: Summary of Safety and Effectiveness GTC Dental Tray 510(k) June 3, 1996 A-1 {1} # I. General Information | Device Name: | Dental Tray for use with the Gill-Thomas-Cosman Relocatable Head Holder, a stereotactic head holder (for LINAC-based stereotactic radiotherapy) | | --- | --- | | Proprietary Trade Name | Gill-Thomas-Cosman (GTC) Dental Tray | | Establishment Registration Number: | 1222895 | | Classification: | Class II / Radiology | | Performance Standard: | No applicable performance standards or special controls have been issued under section 514 of the Food, Drug, and Cosmetic Act. | | Intended Use: | 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. | | Predicate Device: | Dental Tray included in the Gill-Thomas-Cosman Relocatable Head Holder System K934523 | | Manufacturing Facility: | Radionics Software Applications 22 Terry Avenue Burlington, MA 01803 (617) 272-1233 | | Contact Name: | Amy LaForte, Ph.D. | GTC Dental Tray 510(k) June 3, 1996 A-2 {2} ## II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination A summary of the information contained in this 510(k) PMN that addresses safety and effectiveness follows. ### General Safety and Effectiveness Concerns RSA GTC Dental Tray labeling contains instructions for the proper use of this product. It includes a description of the product, directions for use, and applicable safety information. The testing provided in this 510(k) PMN, along with the instructions for use, ensure safe and effective use of the device when followed by the physician. ### Description of the Device and Basis for Substantial Equivalence The material of the GTC Dental Tray has been modified from that described in (K934523). The GTC Dental Tray addressed in this 510(k) PMN has the same intended use, design, and technological characteristics as the Dental Tray included in the commercially available GTC Relocatable Head Holder System (K934523). The Dental Tray holds an impression of the upper teeth as part of the predicate system. This impression allows repeat positioning of the stereotactic frame at the same location, e.g., for multiple lower dose fractionated stereotactic radiotherapy treatments. GTC Dental Tray 510(k) June 3, 1996 A-3 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K962155](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K962155) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com