FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
6649–6672 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 29, 2009
PLANMECA PROSENSOR
K091197 · EHD
Planmeca Oy
Radiology · 97d
Cleared Jul 29, 2009
MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY
K091403 · IXI
Oncology Tech, LLC
Radiology · 78d
Cleared Jul 29, 2009
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001
K092179 · IYN
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Jul 28, 2009
ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
K092159 · IYN
Medison Co., Ltd.
Radiology · 12d
Cleared Jul 24, 2009
MR-TOUCH OPTION
K083421 · LNH
Ge Medical Systems, LLC
Radiology · 247d
Cleared Jul 24, 2009
PICA WHOLE BODY MRI SYSTEM
K091580 · LNH
Time Medical Limited
Radiology · 52d
Cleared Jul 21, 2009
GOLD ANCHOR
K091645 · IYE
Naslund Medical AB
Radiology · 47d
Cleared Jul 21, 2009
BOLUS COMPENSATOR
K091911 · IXI
.Decimal, Inc.
Radiology · 26d
Cleared Jul 21, 2009
QXLINK
K092081 · LLZ
Vieworks Co., Ltd.
Radiology · 12d
Cleared Jul 20, 2009
LEKSELL GAMMAPLAN
K090972 · MUJ
Elekta Instrument AB
Radiology · 105d
Cleared Jul 20, 2009
PERFSCAPE
K091444 · LNH
Olea Medical
Radiology · 66d
Cleared Jul 20, 2009
PROGENY VANTAGE PANORAMIC X-RAY SYSTEM
K091866 · MUH
Midmark
Radiology · 26d
Cleared Jul 20, 2009
DRX-EVOLUTION, MODEL VX3733-SYS
K091889 · KPR
Carestream Health, Inc.
Radiology · 26d
Cleared Jul 17, 2009
OPTIMA MR450W
K091536 · LNH
Ge Medical Systems, LLC
Radiology · 52d
Cleared Jul 17, 2009
BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM
K091558 · MWP
Bioptics, Inc.
Radiology · 50d
Cleared Jul 17, 2009
CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
K091804 · ITX
Philips Ultrasound, Inc.
Radiology · 29d
Cleared Jul 17, 2009
SYNGO VOLUME PERFUSION-CT BODY
K092013 · JAK
Siemens AG Medical Solutions
Radiology · 11d
Cleared Jul 16, 2009
AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
K090914 · JAD
Xoft, Inc.
Radiology · 106d
Cleared Jul 16, 2009
MONACO RTP SYSTEM, VMAT OPTION
K091179 · MUJ
Computerized Medical Systems, Inc.
Radiology · 84d
Cleared Jul 15, 2009
TIGRT TPS
K090893 · MUJ
Linatech, LLC
Radiology · 106d
Cleared Jul 14, 2009
PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260
K090655 · IZL
Source-Ray, Inc.
Radiology · 125d
Cleared Jul 14, 2009
CORONIS 5MP HD, MODEL MDMG 5121
K091274 · LLZ
Barco N.V.
Radiology · 75d
Cleared Jul 14, 2009
RALCO, MODEL R225 ACS
K091517 · IZW
Ralco S.R.L.
Radiology · 53d
Cleared Jul 09, 2009
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K091941 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 9d