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
7321–7344 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jul 16, 2007
SATURN 9000
K063710 · MQB
New Medical Co., Ltd.
Radiology · 214d
Cleared Jul 16, 2007
VARISOURCE IX HDR AFTERLOADER
K071467 · JAQ
Varian Medical Systems, Inc.
Radiology · 48d
Cleared Jul 12, 2007
MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2
K071473 · EOQ
Superdimension, Ltd.
Radiology · 44d
Cleared Jul 11, 2007
BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6
K070611 · IYE
Nomos Corp.
Radiology · 128d
Cleared Jul 11, 2007
SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110
K070634 · IZL
Soyee Product, Inc.
Radiology · 126d
Cleared Jul 11, 2007
EASYGUIDE
K071599 · LLZ
Keystone Dental, Inc.
Radiology · 30d
Cleared Jul 09, 2007
CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS
K071534 · MOS
Confirma, Inc.
Radiology · 34d