← Product Code [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE) · K964840 # BEAM BLOCK TRAYS (K964840) _Aktina Medical Physics Corp. · IYE · Feb 11, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K964840 ## Device Facts - **Applicant:** Aktina Medical Physics Corp. - **Product Code:** [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE.md) - **Decision Date:** Feb 11, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.5050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Therapeutic ## Indications for Use This device is intended to be used as a support for beam shaping or beam defining blocks in the delivery of external beam (photon) radiation therapy. ## Device Story Beam Block Trays support beam shaping/defining blocks for external photon radiation therapy; used in radiation oncology departments; operated by medical physicists or radiation therapists. Device holds shielding blocks in position relative to radiation beam; ensures accurate dose delivery to target tissue while sparing healthy tissue. Benefits include precise beam modulation and patient safety during radiotherapy. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Support tray for radiation therapy beam shaping blocks. Materials and construction identical to predicate. Class II device (21 CFR 892.5050). ## 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 - MED-TEC, Inc. Beam Blocking Trays ([K944315](/device/K944315.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} FEB 11 1997 K964340 # Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act October 16, 1996 ## 1. General Provisions **Common/Usual Name:** Beam Block Trays or Shadow Trays **Proprietary Name:** Beam Block Trays **Applicant Name and Address:** Aktina Medical Physics Corporation 360 North Route 9W Congers, NY 10920 ## 2. Name of Predicate Devices: (1) MED-TEC, Inc. Beam Blocking Trays (K944315) ## 3. Classification This device is classified as a class II device according to 21 CFR 892.5050 ## 4. Performance Standards Performance standards for sheath introducers have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act. ## 5. Intended Use and Device Description This device is intended to be used as a support for beam shaping or beam defining blocks in the delivery of external beam (photon) radiation therapy. ## 6. Biocompatibility No issues of biocompatibility are raised with regard to this device. ## 7. Summary of Substantial Equivalence This device is similar in design and construction, utilizes the identical materials, and has the same intended use and performance Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, "...a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seq. (1977). {1} characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device. --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K964840](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K964840) **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