Name: FDA 510(k) Medical Device Manufacturers
Creator: 510k Database

FDA 510(k) Radiology Device Manufacturers

Medical device manufacturers active in the FDA Radiology review panel, ranked by 510(k) submission volume. Real data from the 510k Database dataset.

Compare manufacturers by FDA 510(k) submission activity

Identify clearance rates, active panels and years of FDA activity

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Radiology Manufacturers

1–50 of 889

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Siemens Medical Solutions USA, Inc. Hoffman Estates	152	100%	CV RA	US
2	Medacta International S.A. Castel San Pietro	99	100%	OR RA SU	CH
3	Boston Scientific Corporation Marlborough	93	99%	AN CV EN +6	US
4	Canon Medical Systems Corporation Otawara-Shi	71	100%	RA	JP
5	Intuitive Surgical, Inc. Sunnyvale	65	100%	EN RA SU	US
6	Shanghai United Imaging Healthcare Co., Ltd. Shanghai	59	100%	RA	CN
7	Medtronic, Inc. Mounds View	54	100%	CV NE OR +2	US
8	Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Shenzhen	50	100%	AN CV RA	CN
9	Varian Medical Systems, Inc. Palo Alto	50	100%	CV GU RA +1	US
10	Philips Medical Systems Nederland B.V. Best	47	98%	AN CV PA +1	NL
11	Depuy Ireland UC Ringaskiddy	46	100%	OR RA	IE
12	GE Medical Systems Ultrasound and Primary Care Diagnostics Wauwatosa	46	100%	RA	US
13	Alphatec Spine, Inc. Carlsbad	43	100%	NE OR RA	US
14	Globus Medical, Inc. Audubon	41	100%	NE OR RA +1	US
15	Brainlab AG Heimstetten	41	100%	EN NE OR +1	DE
16	Olympus Medical Systems Corp. Hachiochi-Shi	38	100%	AN EN GU +4	JP
17	Fujifilm Corporation Ashigara Kami-Gun	35	100%	EN GU RA +1	JP
18	Dentsply Sirona York	33	100%	DE GU HO +1	US
19	Olympus Medical Systems Corporation Melville	31	100%	AN EN GU +3	US
20	Aidoc Medical , Ltd. Tel Aviv	30	100%	RA	IL
21	Samsung Medison Co., Ltd. Seoul	29	100%	RA	KR
22	Roche Molecular Systems, Inc. Somerville	26	96%	HE MI RA	US
23	Ge Medical Systems, LLC Waukesha	24	100%	RA	US
24	KARL STORZ Endoscopy-America, Inc. Mchenry	23	100%	EN GU HO +3	US
25	Siemens Healthcare GmbH Erlangen	23	100%	RA	DE
26	Hologic, Inc. Waltham	22	95%	MI OB PA +1	US
27	GE Medical Systems SCS Buc Cedex	22	100%	RA	FR
28	Lg Electronics.Inc Pyeongtaek-Si	22	100%	RA SU	KR
29	Edan Instruments, Inc. Shenzhen	21	100%	CV OB PM +1	CN
30	Ge Healthcare Waukesha	20	100%	CV HO RA	US
31	Carlsmed, Inc. La Jolla	20	100%	OR RA	US
32	Philips Ultrasound, LLC Bothell	20	100%	RA	US
33	Dentsply Sirona, Inc. York	19	100%	DE HO RA	US
34	Materialise NV Leuven	18	100%	DE NE OR +1	BE
35	Megagen Implant Co., Ltd. Santa Fe Springs	18	100%	DE RA	US
36	Ischemaview, Inc. Irvine	18	100%	RA	US
37	Canon, Inc. Ohta-Ku, Tokyo, Japan	17	100%	OP RA	JP
38	Ewoosoft Co., Ltd. Houston	17	100%	RA	US
39	Iray Technology Taicang , Ltd. Taicang	16	100%	RA	CN
40	Ever Fortune.Ai, Co., Ltd. Taichung City	15	100%	RA	TW
41	Elekta Solutions AB Stockholm	14	100%	RA	SE
42	Medtronic Navigation, Inc. Lafayette	14	100%	EN NE OR +1	US
43	Mim Software, Inc. Cleveland	14	100%	RA	US
44	DRTECH Corporation Seongam-Si	14	100%	RA	KR
45	Osstem Implant Co., Ltd. Busan	13	100%	DE RA	KR
46	Carl Zeiss Meditec, AG Dublin	13	100%	NE OP RA	US
47	Blue Belt Technologies, Inc. Pittsburgh	13	100%	OR RA	US
48	Ziehm Imaging GmbH Orlando	13	100%	RA	US
49	Hyperfine, Inc. Guildford	13	100%	RA	US
50	Nobel Biocare AB Goteborg	12	100%	DE RA	SE

About This FDA 510(k) Manufacturer Database

Data Source and Methodology

Rankings are based on the total number of published FDA 510(k) submissions per manufacturer in the 510k Database dataset, derived from FDA 510(k) public files. This is not a curated or paid listing - manufacturer rankings reflect real regulatory activity.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.