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
9361–9384 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 23, 2001
ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM
K010772 · JAA
Imaging Services, Inc.
Radiology · 162d
Cleared Aug 23, 2001
GE LOGIQ A100 MP, MODEL 2272413
K012560 · IYO
General Electric Co.
Radiology · 15d
Cleared Aug 22, 2001
PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
K011604 · LNI
Ge Medical Systems, Inc.
Radiology · 90d
Cleared Aug 16, 2001
PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM
K012379 · IZL
Trex Enterprises Corp.
Radiology · 21d
Cleared Aug 14, 2001
MODEL 235GE-64
K011608 · MOS
Medical Advances, Inc.
Radiology · 81d
Cleared Aug 14, 2001
MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)
K012289 · IYE
Elekta Oncology Systems, Ltd.
Radiology · 25d
Cleared Aug 14, 2001
HNC-127 NEUROVASCULAR ARRAY COIL
K012353 · MOS
Mri Devices Corp.
Radiology · 20d
Cleared Aug 10, 2001
CYBERKNIFE SYSTEM
K011024 · IYE
Accuray, Inc.
Radiology · 128d
Cleared Aug 10, 2001
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
K012155 · LLZ
Eastman Kodak Company
Radiology · 30d
Cleared Aug 10, 2001
DIGORA PCT
K012170 · MUH
Soredex Palodex Group OY
Radiology · 29d
Cleared Aug 10, 2001
MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER
K012239 · IYN
Hitachi Medical Corp.
Radiology · 24d
Cleared Aug 10, 2001
BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3
K012369 · IYN
Atys Medical
Radiology · 15d
Cleared Aug 10, 2001
HISPEED X/I SMART GANTRY OPTION
K012385 · JAK
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Aug 10, 2001
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM
K012389 · KPR
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Aug 09, 2001
IMAGE-X SYSTEM
K012355 · EHD
Tg Group, Inc.
Radiology · 15d
Cleared Aug 09, 2001
LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
K012373 · IXA
Ferrania S.P.A.
Radiology · 14d
Cleared Aug 07, 2001
CT COLONOGRAPHY/NAVIGATOR2
K012313 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Aug 06, 2001
MUSCLE IMAGING SYSTEM (MIS)
K011416 · LNH
Millennium Magnetic Imaging, Inc.
Radiology · 90d
Cleared Aug 03, 2001
IN SPACE 3D
K011447 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Aug 03, 2001
ADVANCED HIP ASSESSMENT SOFTWARE
K011917 · KGI
Ge Lunar Corp.
Radiology · 44d
Cleared Aug 03, 2001
1.5T INFINITY TWINSPEED MR SYSTEM
K012200 · LNH
GE Medical Systems
Radiology · 21d
Cleared Jul 31, 2001
EXAC TRAC 2.0 (NOVALIS BODY MODULE)
K003285 · IYE
Brainlab AG
Radiology · 285d
Cleared Jul 31, 2001
QCU ANALYTICAL SOFTWARE PACKAGE
K011582 · LLZ
Medis Medical Imaging Systems BV
Radiology · 69d
Cleared Jul 31, 2001
MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES
K012099 · LLZ
Totoku Electric Co., Ltd.
Radiology · 26d