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
7489–7512 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 11, 2007
PORTABLE X-RAY SYSTEM, MODEL PORT-X II
K063121 · EHD
Genoray Co., Ltd.
Radiology · 91d
Cleared Jan 09, 2007
SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM
K063456 · JAD
Topex, Inc.
Radiology · 55d
Cleared Jan 05, 2007
AYCAN WORKSTATION OSIRIX
K063470 · LLZ
Aycan Digitalsysteme GmbH
Radiology · 50d
Cleared Jan 05, 2007
SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K063762 · JAK
Siemens AG Medical Solutions
Radiology · 16d
Cleared Jan 05, 2007
PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE
K063781 · LLZ
Philips Medical Systems North America...
Radiology · 15d
Cleared Jan 05, 2007
ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
K063803 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 14d
Cleared Jan 04, 2007
ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
K063559 · LNH
Philips Medical Systems
Radiology · 38d
Cleared Jan 04, 2007
ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM
K063761 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Dec 29, 2006
NIO FUSION 4MP
K062905 · LLZ
Barcoview
Radiology · 93d
Cleared Dec 28, 2006
COLLIMATOR, MODEL M-38
K062788 · KPW
Umi International
Radiology · 101d
Cleared Dec 26, 2006
CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM
K062265 · IZQ
Swiss Medical Care S.A.
Radiology · 144d
Cleared Dec 26, 2006
AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS
K063262 · IZL
Virtual Imaging
Radiology · 57d
Cleared Dec 26, 2006
HDR CT COMPATIBLE SPLIT RING APPLICATOR
K063382 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 48d
Cleared Dec 26, 2006
CRANEX NOVUS
K063459 · MUH
Soredex Palodex Group OY
Radiology · 41d
Cleared Dec 26, 2006
CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY
K063628 · LLZ
Ge Healthcare Integrated IT Solutions
Radiology · 20d
Cleared Dec 22, 2006
CT COMPATIBLE F/S/D APPLICATORS
K063381 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 44d
Cleared Dec 21, 2006
INTEGRA RADIONICS IMAGEFUSION 3
K063230 · MUJ
Integra Radionics, Inc.
Radiology · 57d
Cleared Dec 21, 2006
FILM DIGITZER, MODEL 2908 MAMMO PRO
K063424 · LMA
Array Corp.
Radiology · 38d
Cleared Dec 21, 2006
I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0
K063493 · IYN
Boston Scientific Corp
Radiology · 31d
Cleared Dec 21, 2006
HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER
K063518 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 30d
Cleared Dec 19, 2006
VISTA AVS
K063600 · JAF
Summit Doppler Systems, Inc.
Radiology · 15d
Cleared Dec 14, 2006
PROTON THERAPY SYSTEM
K062891 · LHN
Indiana University Cyclotron Facility
Radiology · 79d
Cleared Dec 14, 2006
RPM RESPIRATORY GATING SYSTEM
K063270 · IYE
Varian Medical Systems, Inc.
Radiology · 45d
Cleared Dec 14, 2006
CROSSPLAN / ACCUSOFT-XL V.4.04
K063482 · MUJ
Direx Systems Corp.
Radiology · 27d