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
6961–6984 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 05, 2008
Z3D CONTRAST ACUITY
K080196 · LLZ
Clario Medical Imaging, Inc.
Radiology · 224d
Cleared Sep 05, 2008
5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # =...
K081357 · LLZ
Eizo GmbH
Radiology · 114d
Cleared Sep 05, 2008
ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK
K081518 · EOQ
Pentax Medical Company
Radiology · 98d
Cleared Sep 05, 2008
AMICAS PACS, VERSION 6.0
K082144 · LLZ
Amicas, Inc.
Radiology · 37d
Cleared Sep 02, 2008
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER,...
K080711 · KGI
Hologic, Inc.
Radiology · 173d
Cleared Sep 02, 2008
SNAPSHOT
K081925 · MUH
Instrumentarium Dental, Palodex Group OY
Radiology · 57d
Cleared Sep 02, 2008
GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 /...
K082104 · JAK
Ge Medical Systems, Inc.
Radiology · 39d
Cleared Sep 02, 2008
VIVID I AND VIVID Q
K082374 · IYN
Ge Medical Systems Israel,...
Radiology · 15d
Cleared Aug 29, 2008
STEREOS WORKSTATION
K080529 · LLZ
Biospace Med
Radiology · 185d
Cleared Aug 29, 2008
MLCI2
K082122 · IYE
Elekta , Ltd.
Radiology · 32d
Cleared Aug 29, 2008
DSA 2000EX
K082341 · LLZ
Eigen, LLC
Radiology · 14d
Cleared Aug 29, 2008
NORAS MR-BI320-PA 3T
K082373 · MOS
Noras Mri Products GmbH
Radiology · 11d
Cleared Aug 26, 2008
VOLUMINA
K081215 · LLZ
Kjaya Medical, LLC
Radiology · 118d
Cleared Aug 26, 2008
XIOS PLUS WALL-MODULE
K081903 · MUH
Sirona Dental Systems GmbH
Radiology · 54d
Cleared Aug 25, 2008
MODIFICATION TO HI-ART TREATMENT SYSTEM
K082005 · MUJ
Tomotherapy Incorporated
Radiology · 42d
Cleared Aug 25, 2008
SONOSITE MAXX SERIES ULTRASOUND SYSTEM
K082098 · IYN
Sonosite,Inc.
Radiology · 31d
Cleared Aug 25, 2008
CENTRICITY PACS IW
K082318 · LLZ
Ge Healthcare Dynamic Imaging Solutions
Radiology · 12d
Cleared Aug 22, 2008
YSIO
K081722 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Aug 22, 2008
RADVISION ET DIAGNOSTIC X-RAY SYSTEM
K082064 · KPR
Almana Medical Imaging
Radiology · 32d
Cleared Aug 21, 2008
PICASSO MASTER, ECT AND MASTER 3D
K081847 · JAK
E-Woo Technology
Radiology · 52d
Cleared Aug 21, 2008
ANYRAY PORTABLE X-RAY SYSTEM
K081899 · EHD
E-Woo Technology Co., Ltd.
Radiology · 49d
Cleared Aug 21, 2008
PCA-8000A, MARK 11, PET / CT SYSTEM
K082244 · KPS
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Aug 15, 2008
C-INSIGHT
K081672 · LLZ
Mazor Surgical Technologies , Ltd.
Radiology · 63d
Cleared Aug 15, 2008
VERISTA IMAGING ISOCAM II GAMMA CAMERA
K081757 · IYX
Verista Imaging, Inc.
Radiology · 56d