FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
9217–9240 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jul 31, 2001
EFILM WORKSTATION
K012211 · LLZ
Efilm Medical, Inc.
Radiology · 15d
Cleared Jul 26, 2001
RF-IVD WIRELESS DOSIMETER-MODEL 1133
K011332 · IYE
Sun Nuclear Corp.
Radiology · 85d
Cleared Jul 26, 2001
TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC...
K012191 · IYN
Teratech Corp.
Radiology · 13d
Cleared Jul 20, 2001
NORTHEAST PROTON THERAPY CENTER
K983332 · LHN
Massachusetts General Hospital
Radiology · 1032d
Cleared Jul 19, 2001
INFINION ENHANCEMENT PACKAGE
K011296 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 80d
Cleared Jul 17, 2001
AMERITEK BRACHYTHERAPY TEMPLATE
K011581 · ITX
Amertek Medical, Inc.
Radiology · 55d
Cleared Jul 12, 2001
IMMOBILIZATION SYSTEM FOR ENT
K003779 · IYE
Arplay Medical S.A.
Radiology · 217d
Cleared Jul 12, 2001
INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
K011155 · KXK
Ibt, Inc.
Radiology · 87d
Cleared Jul 12, 2001
VARISEED 7.0
K012017 · MUJ
Varian Medical Systems
Radiology · 14d
Cleared Jul 12, 2001
VOXAR VC, MODEL 1.0
K012072 · LLZ
Voxar Limited
Radiology · 10d
Cleared Jul 12, 2001
VORTEX
K012097 · LLZ
Ultravisual Medical Systems
Radiology · 7d
Cleared Jul 12, 2001
PROTON THERAPY SYSTEM
K983024 · LHN
Ion Beam Applications S.A.
Radiology · 1046d