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
7825–7848 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 07, 2006
AIM ACCURACY IN MARKING SYSTEM
K053463 · ITX
Georgene Austria
Radiology · 84d
Cleared Mar 03, 2006
KODAK MODELS 2100 AND 2200
K060292 · EHD
Kodak-Trophy
Radiology · 25d
Cleared Mar 01, 2006
CLINTON ELECTRONICS SERIES II DIGITAL GRAYSCALE MONITORS, MODELS DL2000,...
K053039 · LLZ
Clinton Electronics Corp.
Radiology · 125d
Cleared Feb 28, 2006
CURAY CUSTOM SEED ARRAY
K053595 · KXK
Biolucent, Inc.
Radiology · 67d
Cleared Feb 22, 2006
DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121
K060259 · OWB
Ge Medical Systems, LLC
Radiology · 21d
Cleared Feb 21, 2006
DART-12
K052705 · IYE
Direx Systems Corp.
Radiology · 146d
Cleared Feb 17, 2006
CXR16
K053148 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 99d
Cleared Feb 17, 2006
CEPH, MODEL 4900
K053558 · MUH
Schick Technologies, Inc.
Radiology · 58d
Cleared Feb 16, 2006
JIVE X SOFTWARE
K053183 · LLZ
Visus Technology Transfer GmbH
Radiology · 94d
Cleared Feb 10, 2006
MEDIPORT
K060210 · LLZ
Maxant Technologies, Inc.
Radiology · 14d
Cleared Feb 08, 2006
SIMPLANT DR. JAMES
K053592 · LLZ
Materialise NV
Radiology · 47d
Cleared Feb 08, 2006
KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM
K060079 · MUH
Eastman Kodak Company
Radiology · 29d
Cleared Feb 08, 2006
BIO-RAY SDX DIGITAL X-RAY SYSTEM
K060179 · MUH
Sigma Biomedics, Inc.
Radiology · 16d
Cleared Feb 07, 2006
KODAK PACS
K060055 · LLZ
Eastman Kodak Company
Radiology · 29d
Cleared Feb 03, 2006
CEDARA I-RESPONSE CEDARA PET/CT
K053301 · LLZ
Cedara Software Corp.
Radiology · 67d
Cleared Feb 03, 2006
FRAMELESS RADIOSURGERY COMPONENTS
K053500 · IYE
Brainlab AG
Radiology · 49d
Cleared Feb 03, 2006
BIOGRAPH 6
K060060 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 25d
Cleared Feb 03, 2006
SUNIPAN IMAGING SYSTEM & ACCESSORIES
K060149 · MUH
Suni Medical Imaging, Inc.
Radiology · 14d
Cleared Jan 31, 2006
PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR
K060136 · LLZ
Planar Systems, Inc.
Radiology · 12d
Cleared Jan 27, 2006
MIE - GAMMA CAMERA SYSTEMS
K053086 · KPS
Mie America, Inc.
Radiology · 86d
Cleared Jan 25, 2006
ENCOMPASS.NET
K053455 · LLZ
Empiric Systems, LLC
Radiology · 47d
Cleared Jan 24, 2006
ALTAIRE INTERVENTIONAL MR PACKAGE
K053309 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 57d
Cleared Jan 24, 2006
IBA PROTON THERAPY SYSTEM-PROTEUS 235
K053641 · LHN
Ion Beam Applications S.A.
Radiology · 25d
Cleared Jan 24, 2006
PIONEER TC8080, COMPANION III
K053648 · IYN
Viasys Neuro Care
Radiology · 25d