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
10489–10512 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 29, 1997
BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND...
K972672 · ITX
Barzell-Whitmore Maroon Bells, Inc.
Radiology · 13d
Cleared Jul 25, 1997
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND...
K971660 · FDS
Olympus America, Inc.
Radiology · 80d
Cleared Jul 24, 1997
SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS
K971668 · LNH
GE Medical Systems
Radiology · 79d
Cleared Jul 24, 1997
HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM
K972348 · ITX
Hewlett-Packard Co.
Radiology · 30d
Cleared Jul 23, 1997
TARGET 2 VERSION 1.1
K965010 · IYE
GE Medical Systems
Radiology · 219d
Cleared Jul 23, 1997
CARDIAC PHASED ARRAY COIL
K971667 · MOS
GE Medical Systems
Radiology · 78d
Cleared Jul 23, 1997
SLED, FINGER, HANDLE
K971942 · ITX
Biosound Esaote, Inc.
Radiology · 57d
Cleared Jul 22, 1997
CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM
K962950 · IYE
Varian Medical Systems, Inc.
Radiology · 358d
Cleared Jul 21, 1997
VERIDOSE V (FIVE), MODEL NUMBER 37-705
K964952 · JAD
Victoreen, Inc.
Radiology · 223d
Cleared Jul 21, 1997
FLEXART V3.5 SOFTWARE
K970573 · LNH
Toshiba America Mri, Inc.
Radiology · 157d
Cleared Jul 15, 1997
MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE
K965068 · LNH
Toshiba America Medical Systems, In.C
Radiology · 209d
Cleared Jul 14, 1997
DTX-100 BONE DENSITOMETER
K963789 · KGI
Osteometer Meditech A/S
Radiology · 297d
Cleared Jul 14, 1997
TARGOBEAM
K970819 · JAK
Ferguson Medical
Radiology · 131d
Cleared Jul 14, 1997
ECHOVACS
K971776 · LLZ
Vmi Technologies
Radiology · 62d
Cleared Jul 10, 1997
TRANS VAGINAL NEEDLE GUIDE
K971722 · ITX
Protek Medical Products, Inc.
Radiology · 62d
Cleared Jul 09, 1997
THERAPLAN PLUS VERSION 1.2
K970236 · IYE
Theratronics, Inc.
Radiology · 169d
Cleared Jul 09, 1997
BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER
K971700 · ITX
Biosound, Inc.
Radiology · 62d
Cleared Jul 08, 1997
X-RAY ASSIST BAR
K972000 · KPR
Ralph Lindel, D.C.
Radiology · 39d
Cleared Jul 03, 1997
INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO
K965179 · LLZ
Neo Imagery Technologies, Inc.
Radiology · 191d
Cleared Jul 03, 1997
VERSION 4 OPERATING SYSTEM SOFTWARE
K971279 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 87d
Cleared Jul 03, 1997
MEDISURF
K971347 · LMD
International Regulatory Consultants
Radiology · 84d
Cleared Jul 03, 1997
MEDRAD FLEX INTERFACE DEVICE
K971380 · LNH
Medrad, Inc.
Radiology · 80d
Cleared Jul 03, 1997
RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4
K971489 · IZI
Philips Medical Systems North...
Radiology · 71d
Cleared Jun 26, 1997
THERATRON 780E
K964606 · IWB
Theratronics, Inc.
Radiology · 220d