FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,668 results
10729–10752 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jun 26, 1997
SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)
K964969 · MOS
GE Medical Systems
Radiology · 196d
Cleared Jun 26, 1997
NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES
K971167 · IZD
Neoprobe Corp.
Radiology · 87d
Cleared Jun 26, 1997
IDS4 IMAGE DISPLAY SYSTEM SERIES
K971368 · LLZ
O Tech, Inc.
Radiology · 73d
Cleared Jun 26, 1997
WISE IMAGE MANAGEMENT SYSTEM
K971451 · LMB
O Tech, Inc.
Radiology · 66d
Cleared Jun 26, 1997
TV MONITOR (P12/17)
K972136 · IZI
Perkins Mfg. Co.
Radiology · 20d