Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart F — Therapeutic Devices](/submissions/RA/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 892.5770](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5770) → JAI — Couch, Radiation Therapy, Powered # JAI · Couch, Radiation Therapy, Powered _Radiology · 21 CFR 892.5770 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI ## Overview - **Product Code:** JAI - **Device Name:** Couch, Radiation Therapy, Powered - **Regulation:** [21 CFR 892.5770](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5770) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) - **3rd-party reviewable:** yes ## Identification A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 32) Showing 20 most recent of 32 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K231612](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K231612.md) | Eve Patient Positioner System | Leo Cancer Care | May 7, 2024 | SESE | | [K182683](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K182683.md) | Z-Robot Patient Positioning System | Chinan Biomedical Technology, Inc. | Jun 27, 2019 | SESE | | [K170502](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K170502.md) | Patient Positioning System | Forte Automation Systems, Inc. | Apr 13, 2017 | SESE | | [K160518](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K160518.md) | LEONI ORION System | Leoni Cia Cable System | Jul 14, 2016 | SESE | | [K132084](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K132084.md) | PROTURA COUCH SOFTWARE | Med-Tec, Inc. D/B/A Civco Medical Solutions | Sep 26, 2013 | SESE | | [K122413](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K122413.md) | PATIENT POSITIONING SYSTEM | Forte Automation Systems, Inc. | Sep 13, 2012 | SESE | | [K122201](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K122201.md) | PROTURA COUCH SOFTWARE | Med-Tec, Inc. D/B/A Civco Medical Solutions | Aug 30, 2012 | SESE | | [K120520](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K120520.md) | EXACTRAC ROBOTICS NOVALIS ROBOTICS | Brainlab AG | Jun 29, 2012 | SESE | | [K120916](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K120916.md) | QFIX RADIOTHERAPY CHAIR | Wfr/Aquaplast Corp. | Jun 20, 2012 | SESE | | [K072898](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K072898.md) | HEXAPOD EVO RT COUCH TOP | Medical Intelligence Medizintechnik GmbH | Oct 25, 2007 | SESE | | [K071870](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K071870.md) | HEXAPOD RT COUCH TOP | Medical Intelligence Medizintechnik GmbH | Jul 8, 2007 | SESE | | [K062639](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K062639.md) | MODIFICATION TO HEXAPOD RT COUCH TOP | Medical Intelligence Medizintechnik-GmbH-An Elekta | Sep 21, 2006 | SESE | | [K060870](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K060870.md) | AVANZA | Mds Nordion | May 15, 2006 | SESE | | [K060671](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K060671.md) | KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS | Wfr/Aquaplast Corp. | May 4, 2006 | SESE | | [K050422](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K050422.md) | 550 TXT TREATMENT TABLE | Siemens Medical Solutions USA, Inc. | Mar 18, 2005 | SESE | | [K042146](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K042146.md) | ROBOCOUCH PATIENT SUPPORT SYSTEM | Accuray Incorporated | Sep 17, 2004 | SESE | | [K041448](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K041448.md) | HEXAPOD RT COUCHTOP | Medical Intelligence Medizintechnik GmbH | Jun 16, 2004 | SESE | | [K033316](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K033316.md) | TABLE TILT DEVICE | Brainlab AG | May 14, 2004 | SESE | | [K034054](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K034054.md) | PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 | Med-Tec,Inc. | Feb 20, 2004 | SESE | | [K031866](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI/K031866.md) | MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC | Med-Tec,Inc. | Aug 14, 2003 | SESE | ## Top Applicants - Medical Intelligence Medizintechnik GmbH — 3 clearances - Nomos Corp. — 3 clearances - Brainlab AG — 2 clearances - Forte Automation Systems, Inc. — 2 clearances - Med-Tec, Inc. D/B/A Civco Medical Solutions — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAI) **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