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
9025–9048 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 13, 2002
IMPLANT GUIDANCE SYSTEM APPLICATOR SET
K020015 · JAQ
Nucletron Corp.
Radiology · 69d
Cleared Mar 13, 2002
MODIFICATION TO MAGNETOM RHAPSODY SYSTEM
K020573 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 44d
Cleared Mar 13, 2002
NVA-63-8 NEUROVASCULAR ARRAY COIL
K020606 · MOS
Mri Devices Corp.
Radiology · 16d
Cleared Mar 12, 2002
PREFERNCE IMRT TREATMENT PLANNING MODULE
K012575 · MUJ
Northwest Medical Physics Equipment,...
Radiology · 215d
Cleared Mar 07, 2002
VIATRONIX V3D COLON
K020658 · LLZ
Viatronix, Inc.
Radiology · 6d
Cleared Mar 05, 2002
AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES
K014081 · IYE
Aktina Medical Physics Corp.
Radiology · 84d
Cleared Mar 05, 2002
LASERPRO 16
K020243 · LMA
Eradlink, Inc.
Radiology · 41d
Cleared Mar 04, 2002
NEUROSPECTQUAD GAMMA CAMERA
K013353 · KPS
Nuclear Cardiology Systems, Inc.
Radiology · 146d
Cleared Mar 04, 2002
MRI LINE MARKER
K014022 · IYE
I.Z.I. Corp.
Radiology · 88d
Cleared Mar 04, 2002
SONOREAL 3D SYSTEM
K020068 · IYO
Bio Medi Com
Radiology · 54d
Cleared Mar 01, 2002
KONICA DIRECT DIGITIZER REGIUS MODEL 350
K013054 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 171d
Cleared Feb 28, 2002
ADVANTAGE WORKSTATION 4.1
K020483 · LLZ
GE Medical Systems
Radiology · 15d
Cleared Feb 25, 2002
WAVELENGHT ULTRASOUND LOTION
K013212 · MUI
National Therapy Products, Inc.
Radiology · 153d
Cleared Feb 22, 2002
CP-SLEEVE
K013975 · KXK
Cp Medical
Radiology · 81d
Cleared Feb 22, 2002
EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS
K014033 · KPS
Syntermed, Inc.
Radiology · 77d
Cleared Feb 22, 2002
PORTABLE X-RAY UNITS
K020436 · IZL
Sedecal., Sa.
Radiology · 14d
Cleared Feb 20, 2002
BABYCOM
K013547 · KNG
Pmg Medica , Ltd.
Radiology · 119d
Cleared Feb 15, 2002
CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT)
K011147 · EHD
Cavitat Medical Technologies, Inc.
Radiology · 305d
Cleared Feb 15, 2002
VCS-A SERIES CLAMP
K011863 · DXC
Vascular Control Systems, Inc.
Radiology · 246d
Cleared Feb 15, 2002
CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A
K020385 · JAK
Toshiba America Medical Systems, In.C
Radiology · 10d
Cleared Feb 13, 2002
OMNIA X/XS ULTRASOUND SYSTEM
K020353 · IYN
Siemens Medical Systems, Inc.
Radiology · 9d
Cleared Feb 12, 2002
ORION DIGITAL IMAGING SYSTEM
K012490 · OWB
Infimed, Inc.
Radiology · 193d
Cleared Feb 12, 2002
E-SCAN XQ
K020164 · LNH
Biosound Esaote, Inc.
Radiology · 26d
Cleared Feb 11, 2002
MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER
K013722 · IYN
Hitachi Medical Corp.
Radiology · 94d