JAD · Class II · 21 CFR 892.5900

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

Leading manufacturers include Icad, Inc., Sensus Healthcare and Sensus Healthcare, Inc..

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 29, 2017
Photoelectric Therapy System
K172080
Xstrahl, Ltd.
Radiology · 81d
Cleared Dec 15, 2016
INTRABEAM 600
K162568
Carl Zeiss Meditec, AG
Radiology · 92d
Cleared Feb 25, 2016
Axxent Electronic Brachytherapy System Model 110 XP 1200
K153570
Icad, Inc.
Radiology · 73d
Cleared Oct 16, 2015
Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
K150037
Sensus Healthcare
Radiology · 280d
Cleared Sep 05, 2014
AXXENT CERVICAL APPLICATOR
K141343
Icad, Inc.
Radiology · 107d
Cleared Sep 26, 2013
ESTEYA
K132092
Nucletron B.V.
Radiology · 83d
Cleared Aug 28, 2013
SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM
K131582
Sensus Healthcare
Radiology · 89d
Cleared Jun 26, 2013
INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR
K130549
Carl Zeiss Meditec, Inc.
Radiology · 114d
Cleared May 14, 2013
SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100
K123985
Sensus Healthcare
Radiology · 139d
Cleared Jan 17, 2013
XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110
K122951
Icad, Inc.
Radiology · 114d
Cleared Dec 27, 2012
INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS
K121653
Carl Zeiss Meditec, Inc.
Radiology · 205d
Cleared Apr 13, 2012
INTRABEAM NEEDLE APPLICATOR
K110590
Carl Zeiss Surgical GmbH
Radiology · 408d
Cleared Jul 20, 2011
AXXENT RADIATION SHIELD - RIGID
K111299
Xoft, an Icad Company
Radiology · 72d
Cleared Dec 22, 2005
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
K050843
Xoft, Inc.
Radiology · 265d
Cleared May 23, 2005
INTRABEAM SYSTEM
K051055
Carl Zeiss Surgical GmbH
Radiology · 27d
Cleared Sep 23, 1999
PHOTON RADIOSURGERY SYSTEM (PRS)
K992577
Photoelectron Corporation
Radiology · 52d
Cleared Jul 27, 1998
PHOTON RADIOSURGERY SYSTEM PRS400
K980526
Pec Photoelectron Corp.
Radiology · 167d

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 →