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
9169–9192 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 04, 2002
GE VIVID 3 EXPERT
K020789 · IYN
General Electric Co.
Radiology · 24d
Cleared Apr 03, 2002
MFCD 118I
K020059 · LLZ
Barco N.V.
Radiology · 85d
Cleared Apr 03, 2002
IMAGEDESK
K020061 · LLZ
Barco N.V.
Radiology · 85d
Cleared Apr 03, 2002
CT-C3000 SPIRAL CT SCANNER SYSTEM
K020913 · JAK
Neusoft Digital Medical Systems Co.,...
Radiology · 13d
Cleared Apr 03, 2002
SMARTSCORE 3.5
K020929 · JAK
GE Medical Systems
Radiology · 12d
Cleared Apr 02, 2002
CROSSPOINT TRANSACCESS CATHETER
K013363 · ITX
Trans Vascular Incorporated
Radiology · 174d
Cleared Mar 26, 2002
M3 (MIRCO-MULTILEAF COLLIMATOR
K004022 · IYE
Brainlab AG
Radiology · 454d
Cleared Mar 26, 2002
MOONRAY MOBILE C-ARM
K013426 · OXO
Simad S.R.L.
Radiology · 161d
Cleared Mar 26, 2002
CARD IQ ANALYSIS II
K020796 · JAK
GE Medical Systems
Radiology · 14d
Cleared Mar 22, 2002
PRONTO
K014240 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 86d
Cleared Mar 21, 2002
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622
K020635 · MQB
Eastman Kodak Company
Radiology · 22d
Cleared Mar 15, 2002
PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION
K020055 · JAA
Philips Medical Systems
Radiology · 66d
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