JAA · System, X-Ray, Fluoroscopic, Image-Intensified

Device class

Class II

Regulation 892.1650

Total clearances

2020-03-06 → 2026-05-29

Last 12 months

Unique sponsors

Classification details

Medical specialty

Radiology

Review panel

Regulation number

892.1650

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Philips Medical Systems Dmc GmbH	4	0	2024-01-11
Imaging Engineering, LLC	3	1	2025-09-16
Dornier Medtech America, Inc.	2	0	2024-06-26
Omega Medical Imaging, LLC	2	0	2025-01-06
Canon Medical Systems Corporation	1	0	2023-09-12
Nrt X-Ray A/S	1	0	2024-12-23
Cmt Medical Technologies, Ltd.	1	0	2020-09-03
Karl Storz Endoscopy America, Inc.	1	0	2020-12-29
Agfa N.V.	1	0	2021-08-31
Varex Imaging Corporation	1	1	2026-05-29
Apelem-Dms Group	1	0	2021-01-22
Ziehm Imaging GmbH	1	0	2021-03-17

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
74000	CPT	—	Medium	Fluoroscopy, single plane; image-intensified fluoroscopic X-ray systems bill under fluoroscopy codes
76999	CPT	—	Medium	Unlisted radiographic procedure for general fluoroscopy systems

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-05-29	K253103	Varex Imaging Corporation	Nexus DRF Digital X-ray Imaging System
2025-09-16	K251650	Imaging Engineering, LLC	Insight Enhanced DRF (EN-1002-01)
2025-01-06	K242488	Omega Medical Imaging, LLC	Soteria E-View
2024-12-23	K242948	Nrt X-Ray A/S	Adora DRFi (04550010)
2024-06-26	K233380	Dornier Medtech America	TRIDENT Mobile Fluoroscopy System
2024-01-11	K233945	Philips Medical Systems Dmc GmbH	ProxiDiagnost N90 / Precision CRF (706110, 706400)
2023-10-19	K232910	Philips Medical Systems Dmc GmbH	CombiDiagnost R90
2023-09-12	K232526	Canon Medical Systems Corporation	XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
2022-04-18	K220871	Dornier Medtech America, Inc.	Nautilus
2021-12-13	K212890	Omega Medical Imaging, LLC	Nyquist.IQ
2021-09-21	K212837	Philips Medical Systems Dmc GmbH	ProxiDiagnost N90
2021-08-31	K212145	Agfa N.V.	DR 800 with DSA, DR 800
2021-07-27	K210469	Imaging Engineering, LLC	Insight Agile DRF
2021-03-17	K203428	Ziehm Imaging GmbH	Ziehm Vision RFD
2021-01-22	K203010	Apelem-Dms Group	Platinum dRF Imaging System
2020-12-29	K200965	Karl Storz Endoscopy America, Inc.	XR-MX/1000
2020-12-03	K203087	Philips Medical Systems Dmc GmbH	CombiDiagnost R90
2020-09-03	K202235	Cmt Medical Technologies, Ltd.	ArtPIX DRF
2020-03-06	K200396	Imaging Engineering, LLC	Insight Enhanced DRF Digital Imaging System