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
7345–7368 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 15, 2007
HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)
K071992 · IYE
Varian Medical Systems
Radiology · 26d
Cleared Aug 14, 2007
MAGNETOM ESSENZA
K071925 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 33d
Cleared Aug 14, 2007
20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2)
K072065 · LLZ
Totoku Electric Co., Ltd.
Radiology · 18d
Cleared Aug 14, 2007
1.3M MONOCHROME LCD MONITOR MDL1908A
K072066 · LLZ
Totoku Electric Co., Ltd.
Radiology · 18d
Cleared Aug 14, 2007
IGUIDE SYSTEM
K072079 · IYE
Medical Intelligence...
Radiology · 15d
Cleared Aug 09, 2007
CODIAGNOSTIX (R) 5.72
K071636 · LLZ
Ivs Solutions AG
Radiology · 55d
Cleared Aug 09, 2007
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K071873 · MUJ
Varian Medical Systems, Inc.
Radiology · 34d
Cleared Aug 07, 2007
QUANTUM DIREX SYSTEM
K072010 · KPR
Quantum Medical Imaging, LLC
Radiology · 15d
Cleared Aug 03, 2007
AXIS-V MONOCHROME 5 MP DISPLAY
K063066 · LLZ
National Display Systems
Radiology · 301d
Cleared Aug 03, 2007
PXS-810, PODIATRY X-RAY SYSTEM
K071392 · KPR
Source-Ray, Inc.
Radiology · 77d
Cleared Aug 03, 2007
MYLAB30, MODEL 7300
K071996 · IYO
Esaote, S.P.A.
Radiology · 8d
Cleared Jul 30, 2007
A-VIEW BASIC AND PLUS
K070515 · ITX
Cordatec N.V.
Radiology · 158d
Cleared Jul 30, 2007
ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS
K071972 · LLZ
Agfa Healthcare Corp.
Radiology · 13d
Cleared Jul 30, 2007
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0
K072000 · IYN
Toshiba America Medical Systems, In.C
Radiology · 7d
Cleared Jul 27, 2007
SYNGO TRUED
K071950 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 11d
Cleared Jul 26, 2007
SYSTEM, TOMOGRAPHY, COMPUTED EMISSION
K071503 · KPS
Syntermed, Inc.
Radiology · 55d
Cleared Jul 23, 2007
UNIWEB, VERSION 5.0
K071166 · LLZ
Electronic Business Machine Co., Ltd....
Radiology · 88d
Cleared Jul 23, 2007
IMAGIC V2.0
K071602 · LLZ
Ashva Technologies, Pvt., Ltd.
Radiology · 42d
Cleared Jul 23, 2007
TRACKLEAF-10
K071701 · IYE
Direx Systems Corp.
Radiology · 32d
Cleared Jul 23, 2007
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP -...
K071847 · MOS
Shanghai Chenguang Medical...
Radiology · 18d
Cleared Jul 18, 2007
GAMMAMEDPLUS IX SERIES HDR AFTERLOADER
K071381 · JAQ
Varian Medical Systems
Radiology · 62d
Cleared Jul 18, 2007
PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
K071550 · KXK
Cp Medical
Radiology · 42d
Cleared Jul 18, 2007
ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032
K071673 · IYE
Onc Solutions, Inc.
Radiology · 29d
Cleared Jul 18, 2007
MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH,
K071882 · MOS
Shanghai Chenguang Medical...
Radiology · 9d