FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
6697–6720 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 16, 2009
MONACO RTP SYSTEM, VMAT OPTION
K091179 · MUJ
Computerized Medical Systems, Inc.
Radiology · 84d
Cleared Jul 16, 2009
AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
K090914 · JAD
Xoft, Inc.
Radiology · 106d
Cleared Jul 15, 2009
TIGRT TPS
K090893 · MUJ
Linatech, LLC
Radiology · 106d
Cleared Jul 14, 2009
RALCO, MODEL R225 ACS
K091517 · IZW
Ralco S.R.L.
Radiology · 53d
Cleared Jul 14, 2009
CORONIS 5MP HD, MODEL MDMG 5121
K091274 · LLZ
Barco N.V.
Radiology · 75d
Cleared Jul 14, 2009
PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260
K090655 · IZL
Source-Ray, Inc.
Radiology · 125d
Cleared Jul 09, 2009
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K091941 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 9d
Cleared Jul 07, 2009
PACSMATE, MODEL MMD-4300C/MMD-4300CX
K091687 · LLZ
Iei Technology Corp.
Radiology · 27d
Cleared Jul 07, 2009
TIGRT MLC, TIGRT DMLC
K090802 · IYE
Linatech, LLC
Radiology · 105d
Cleared Jul 07, 2009
PACS PLUS 5TH EDITION
K083658 · LLZ
Medical Standard Co., Ltd.
Radiology · 209d
Cleared Jul 02, 2009
MAMMOSITE II RADIATION THERAPY SYSTEM
K091378 · JAQ
Hologic, Inc.
Radiology · 52d
Cleared Jul 01, 2009
FLAATZ 500
K091747 · KPR
Drtech Corp.
Radiology · 15d
Cleared Jun 30, 2009
SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION
K090268 · IZL
Shimadzu Corp.
Radiology · 147d
Cleared Jun 30, 2009
IDR
K082450 · MQB
Icrco, Inc.
Radiology · 309d
Cleared Jun 29, 2009
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA...
K091658 · OWB
Ge Healthcare
Radiology · 20d
Cleared Jun 29, 2009
LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798,...
K091598 · JAQ
Nucletron Corp.
Radiology · 26d
Cleared Jun 29, 2009
TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE...
K091325 · KGI
Cooper Surgical
Radiology · 55d
Cleared Jun 29, 2009
MR CARDIAC FUNCTION ANALYSIS
K091262 · LLZ
Ziosoft, Inc.
Radiology · 61d
Cleared Jun 29, 2009
MYRIAN 1.4
K091001 · LLZ
Intrasense
Radiology · 82d
Cleared Jun 29, 2009
DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D
K083640 · KPR
Choong Wae Medical Corp.
Radiology · 202d
Cleared Jun 24, 2009
GE LIGHTSPEED ACT FP16
K091673 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Jun 24, 2009
NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230
K091546 · MOS
Noras Mri Products GmbH
Radiology · 28d
Cleared Jun 23, 2009
PORTALVISION ADVANCED IMAGING
K091209 · IYE
Varian Medical Systems, Inc.
Radiology · 60d
Cleared Jun 23, 2009
VISION TOOLS
K090668 · LLZ
Millensys
Radiology · 102d