JAD · Class II · 21 CFR 892.5900

FDA Product Code JAD: System, Therapeutic, X-ray

Leading manufacturers include Sensus Healthcare, Inc., Xstrahl, Ltd. and Carl Zeiss Meditec, AG.

53
Total
53
Cleared
119d
Avg days
1978
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 265d recently vs 114d historically

FDA 510(k) Cleared System, Therapeutic, X-ray Devices (Product Code JAD)

53 devices
1–24 of 53
Cleared Dec 03, 2025
GentleBeam (GB1000)
K250692
Voxel Ray Solutions, LLC
Radiology · 271d
Cleared Jan 10, 2025
INTRABEAM (700)
K241174
Carl Zeiss Meditec, AG
Radiology · 259d
Cleared Jul 13, 2023
X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)
K230611
Xstrahl, Ltd.
Radiology · 129d
Cleared Jan 11, 2022
Esteya
K213942
Nucletron B.V.
Radiology · 25d
Cleared Feb 21, 2019
Sensus IORT System
K182641
Sensus Healthcare, Inc.
Radiology · 150d
Cleared Feb 21, 2019
Sensus Healthcare TVM Balloon Applicator
K190255
Sensus Healthcare, Inc.
Radiology · 14d
Cleared Mar 23, 2018
SRT-100+
K173425
Sensus Healthcare, Inc.
Radiology · 141d
Cleared Sep 21, 1990
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K903377
Siemens Medical Solutions USA, Inc.
Radiology · 53d

About Product Code JAD - Regulatory Context

510(k) Submission Activity

53 total 510(k) submissions under product code JAD since 1978, with 53 receiving FDA clearance (average review time: 119 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - JAD Product Code

Recent submissions under JAD have taken an average of 265 days to reach a decision - up from 114 days historically. Manufacturers should account for longer review timelines in current project planning.

JAD devices are reviewed by the Radiology panel. Browse all Radiology devices →