Product code JAI— Radiology
PROTURA COUCH SOFTWARE
- Classification name
- Couch, Radiation Therapy, Powered
- Device class
- Class 2
- Regulation
- 21 CFR 892.5770
- Advisory panel
- Radiology
- Total cleared
- 32
- First cleared
- Most recent
Market context for product code JAI
FDA has cleared devices under product code JAI between 1983 and 2024, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2019
- 2017
- 2016
- 2013
- 2012
- 2007
- 2006
- 2005
- 2004
- 2003
- 2001
- 2000
- 1999
- 1998
Top applicants under product code JAI
Recent clearances under product code JAI
- K231612 — Eve Patient Positioner System
- K182683 — Z-Robot Patient Positioning System
- K170502 — Patient Positioning System
- K160518 — LEONI ORION System
- K132084 — PROTURA COUCH SOFTWARE
- K122413 — PATIENT POSITIONING SYSTEM
- K122201 — PROTURA COUCH SOFTWARE
- K120520 — EXACTRAC ROBOTICS NOVALIS ROBOTICS
- K120916 — QFIX RADIOTHERAPY CHAIR
- K072898 — HEXAPOD EVO RT COUCH TOP
- K071870 — HEXAPOD RT COUCH TOP
- K062639 — MODIFICATION TO HEXAPOD RT COUCH TOP
- K060870 — AVANZA
- K060671 — KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS
- K050422 — 550 TXT TREATMENT TABLE
- K042146 — ROBOCOUCH PATIENT SUPPORT SYSTEM
- K041448 — HEXAPOD RT COUCHTOP
- K033316 — TABLE TILT DEVICE
- K034054 — PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100
- K031866 — MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC
- K013036 — NOMOS MOTORIZED CRANE II
- K993522 — AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT
- K983678 — ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE
- K982446 — DYNAMIC SHIELDING RADIATION TABLE
- K964740 — THE NOMOS MINICRANE
- K941927 — THE NOMOS CRANE
- K910002 — GENESYS AND THE ROI
- K910648 — THERAPY CHAIR SYSTEM
- K910971 — Z XT RADIATION THERAPY TREATMENT TABLE
- K855063 — UNIVERSAL PATIENT CHAIR UNI 2000X
- K834201 — TCT-1 TREATMENT COUCH
- K837152 — THERAC 25 LINEAR ACCELERATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.