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
9001–9024 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 23, 2002
NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)
K020300 · KPS
Syntermed, Inc.
Radiology · 84d
Cleared Apr 23, 2002
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL,...
K020495 · MOS
Surgi-Vision, Inc.
Radiology · 68d
Cleared Apr 22, 2002
MOTION TRACKING
K020294 · IYE
Accuray, Inc.
Radiology · 84d
Cleared Apr 19, 2002
50S TRINGA ULTRASOUND IMAGING SYSTEM
K020112 · IYO
Pie Medical
Radiology · 98d
Cleared Apr 17, 2002
OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
K021049 · OWB
Ge Oec Medical Systems
Radiology · 16d
Cleared Apr 12, 2002
EFILM WORKSTATION WITH MODULES
K020995 · LLZ
Efilm Medical, Inc.
Radiology · 15d
Cleared Apr 10, 2002
UD-1000 ULTRASONIC A/B SCANNER
K020151 · IYO
Tomey Corp. USA
Radiology · 84d
Cleared Apr 08, 2002
AL-2000 COMBINED BIOMETER AND PACHYMETER
K012803 · IYO
Tomey Corp.
Radiology · 230d
Cleared Apr 08, 2002
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000
K013848 · IYN
U-Systems, Inc.
Radiology · 139d
Cleared Apr 08, 2002
HDR MIAMI APPLICATOR
K020176 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 80d
Cleared Apr 04, 2002
ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH...
K013088 · IYO
Echotech 3D Imaging Systems, Inc.
Radiology · 199d
Cleared Apr 04, 2002
MEDICAL LE
K020058 · LLZ
Barco N.V.
Radiology · 86d
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