Product Code: JAI FDA class 2 21 CFR 892.5770

Couch, Radiation Therapy, Powered

Radiology

A powered radiation therapy couch is a motorized patient positioning table used in radiation therapy to precisely position and reposition patients relative to the treatment beam, enabling accurate delivery of therapeutic doses to the target volume. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JAI, regulated under 21 CFR 892.5770, within the Radiology medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: JAI
Device Class: FDA class 2
Regulation Number: 892.5770
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K231612	Eve Patient Positioner System	May 07, 2024	Substantially Equivalent	Leo Cancer Care
K182683	Z-Robot Patient Positioning System	Jun 27, 2019	Substantially Equivalent	Chinan Biomedical Technology, Inc.
K170502	Patient Positioning System	Apr 13, 2017	Substantially Equivalent	Forte Automation Systems, Inc.
K160518	LEONI ORION System	Jul 14, 2016	Substantially Equivalent	Leoni Cia Cable System
K132084	PROTURA COUCH SOFTWARE	Sep 26, 2013	Substantially Equivalent	Med-Tec, Inc. D/B/A Civco Medical Solutions
K122413	PATIENT POSITIONING SYSTEM	Sep 13, 2012	Substantially Equivalent	Forte Automation Systems, Inc.
K122201	PROTURA COUCH SOFTWARE	Aug 30, 2012	Substantially Equivalent	Med-Tec, Inc. D/B/A Civco Medical Solutions
K120520	EXACTRAC ROBOTICS NOVALIS ROBOTICS	Jun 29, 2012	Substantially Equivalent	Brainlab AG
K120916	QFIX RADIOTHERAPY CHAIR	Jun 20, 2012	Substantially Equivalent	Wfr/Aquaplast Corp.
K072898	HEXAPOD EVO RT COUCH TOP	Oct 25, 2007	Substantially Equivalent	Medical Intelligence Medizintechnik GmbH
K071870	HEXAPOD RT COUCH TOP	Jul 08, 2007	Substantially Equivalent	Medical Intelligence Medizintechnik GmbH
K062639	MODIFICATION TO HEXAPOD RT COUCH TOP	Sep 21, 2006	Substantially Equivalent	Medical Intelligence Medizintechnik-GmbH-An Elekta
K060870	AVANZA	May 15, 2006	Substantially Equivalent	Mds Nordion
K060671	KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS	May 04, 2006	Substantially Equivalent	Wfr/Aquaplast Corp.
K050422	550 TXT TREATMENT TABLE	Mar 18, 2005	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K042146	ROBOCOUCH PATIENT SUPPORT SYSTEM	Sep 17, 2004	Substantially Equivalent	Accuray Incorporated
K041448	HEXAPOD RT COUCHTOP	Jun 16, 2004	Substantially Equivalent	Medical Intelligence Medizintechnik GmbH
K033316	TABLE TILT DEVICE	May 14, 2004	Substantially Equivalent	Brainlab AG
K034054	PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100	Feb 20, 2004	Substantially Equivalent	Med-Tec,Inc.
K031866	MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC	Aug 14, 2003	Substantially Equivalent	Med-Tec,Inc.
K013036	NOMOS MOTORIZED CRANE II	Dec 07, 2001	Substantially Equivalent	Nomos Corp.
K993522	AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT	Jan 10, 2000	Substantially Equivalent	Aktina Medical Physics Corp.
K983678	ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE	Jan 15, 1999	Substantially Equivalent	Elekta Instruments, Inc.
K982446	DYNAMIC SHIELDING RADIATION TABLE	Sep 29, 1998	Substantially Equivalent	American Biophysics, Inc.
K964740	THE NOMOS MINICRANE	Feb 11, 1997	Substantially Equivalent	Nomos Corp.
K941927	THE NOMOS CRANE	Feb 09, 1995	Substantially Equivalent	Nomos Corp.
K910648	THERAPY CHAIR SYSTEM	Jul 22, 1991	Substantially Equivalent	Radiation Technology, Inc.
K910002	GENESYS AND THE ROI	Jul 22, 1991	Substantially Equivalent	The Complete Systems Corp. Genesys
K910971	Z XT RADIATION THERAPY TREATMENT TABLE	May 03, 1991	Substantially Equivalent	Siemens Medical Laboratories, Inc.
K855063	UNIVERSAL PATIENT CHAIR UNI 2000X	Jan 30, 1986	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K834201	TCT-1 TREATMENT COUCH	Mar 05, 1984	Substantially Equivalent	Therados, Inc.
K837152	THERAC 25 LINEAR ACCELERATOR	Mar 22, 1983	Substantially Equivalent	Atomic Energy of Canada