JAA · Class II · 21 CFR 892.1650

FDA Product Code JAA: System, X-ray, Fluoroscopic, Image-intensified

Leading manufacturers include General Electric Co., Siemens Medical Solutions USA, Inc. and Omega Medical Imaging, LLC.

300
Total
300
Cleared
89d
Avg days
1976
Since
Stable submission activity - 4 submissions in the last 2 years
Review times increasing: avg 146d recently vs 88d historically

FDA 510(k) Cleared System, X-ray, Fluoroscopic, Image-intensified Devices (Product Code JAA)

300 devices
1–24 of 300
Cleared May 29, 2026
Nexus DRF Digital X-ray Imaging System
K253103
Varex Imaging Corporation
Radiology · 247d
Cleared Sep 16, 2025
Insight Enhanced™ DRF (EN-1002-01)
K251650
Imaging Engineering, LLC
Radiology · 110d
Cleared Jan 06, 2025
Soteria E-View
K242488
Omega Medical Imaging, LLC
Radiology · 138d
Cleared Dec 23, 2024
Adora DRFi (04550010)
K242948
Nrt X-Ray A/S
Radiology · 89d
Cleared Jun 26, 2024
TRIDENT Mobile Fluoroscopy System
K233380
Dornier Medtech America
Radiology · 268d
Cleared Jan 11, 2024
ProxiDiagnost N90 / Precision CRF (706110, 706400)
K233945
Philips Medical Systems Dmc GmbH
Radiology · 28d
Cleared Oct 19, 2023
CombiDiagnost R90
K232910
Philips Medical Systems Dmc GmbH
Radiology · 30d
Cleared Sep 12, 2023
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
K232526
Canon Medical Systems Corporation
Radiology · 22d
Cleared Apr 18, 2022
Nautilus
K220871
Dornier Medtech America, Inc.
Radiology · 24d
Cleared Dec 13, 2021
Nyquist.IQ
K212890
Omega Medical Imaging, LLC
Radiology · 94d
Cleared Sep 21, 2021
ProxiDiagnost N90
K212837
Philips Medical Systems Dmc GmbH
Radiology · 14d
Cleared Aug 31, 2021
DR 800 with DSA, DR 800
K212145
Agfa N.V.
Radiology · 53d
Cleared Jul 27, 2021
Insight Agile DRF
K210469
Imaging Engineering, LLC
Radiology · 161d
Cleared Mar 17, 2021
Ziehm Vision RFD
K203428
Ziehm Imaging GmbH
Radiology · 117d
Cleared Jan 22, 2021
Platinum dRF Imaging System
K203010
Apelem-Dms Group
Radiology · 113d
Cleared Dec 29, 2020
XR-MX/1000
K200965
KARL STORZ Endoscopy-America, Inc.
Radiology · 263d
Cleared Dec 03, 2020
CombiDiagnost R90
K203087
Philips Medical Systems Dmc GmbH
Radiology · 51d
Cleared Sep 03, 2020
ArtPIX DRF
K202235
Cmt Medical Technologies, Ltd.
Radiology · 27d
Cleared Mar 06, 2020
Insight Enhanced DRF Digital Imaging System
K200396
Imaging Engineering, LLC
Radiology · 17d
Cleared Oct 04, 2019
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)
K191713
Omega Medical Imaging, LLC
Radiology · 100d
Cleared Aug 16, 2019
PowerDR
K191504
Radiology Information Systems, Inc.
Radiology · 71d
Cleared Aug 05, 2019
FLUOROspeed
K191877
Shimadzu Corporation
Radiology · 21d
Cleared Jun 10, 2019
Insight Essentials DRF Digital Imaging System
K191310
Imaging Engineering, LLC
Radiology · 26d
Cleared Mar 29, 2019
CS-series-FP with Optional ROI Accessory CA-100S
K182834
Omega Medical Imaging, LLC
Radiology · 171d

About Product Code JAA - Regulatory Context

510(k) Submission Activity

300 total 510(k) submissions under product code JAA since 1976, with 300 receiving FDA clearance (average review time: 89 days).

Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.

FDA 510(k) Review Time - JAA Product Code

Recent submissions under JAA have taken an average of 146 days to reach a decision - up from 88 days historically. Manufacturers should account for longer review timelines in current project planning.

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