JAI · Class II · 21 CFR 892.5770

FDA Product Code JAI: Couch, Radiation Therapy, Powered

Leading manufacturers include Brainlab AG, Siemens Medical Solutions USA, Inc. and Chinan Biomedical Technology, Inc..

32
Total
32
Cleared
105d
Avg days
1983
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Couch, Radiation Therapy, Powered Devices (Product Code JAI)

32 devices
1–24 of 32
Cleared May 07, 2024
Eve Patient Positioner System
K231612
Leo Cancer Care
Radiology · 340d
Cleared Jun 27, 2019
Z-Robot Patient Positioning System
K182683
Chinan Biomedical Technology, Inc.
Radiology · 274d
Cleared Jun 29, 2012
EXACTRAC ROBOTICS NOVALIS ROBOTICS
K120520
Brainlab AG
Radiology · 129d
Cleared Mar 18, 2005
550 TXT TREATMENT TABLE
K050422
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared May 14, 2004
TABLE TILT DEVICE
K033316
Brainlab AG
Radiology · 212d
Cleared Jan 30, 1986
UNIVERSAL PATIENT CHAIR UNI 2000X
K855063
Siemens Medical Solutions USA, Inc.
Radiology · 43d

About Product Code JAI - Regulatory Context

510(k) Submission Activity

32 total 510(k) submissions under product code JAI since 1983, with 32 receiving FDA clearance (average review time: 105 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.