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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
6937–6960 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 04, 2008
DISCOVERY MR450
K083147 · LNH
Ge Medical Systems, LLC
Radiology · 11d
Cleared Oct 31, 2008
MASTER3DS
K082410 · OAS
E-Woo Technology
Radiology · 71d
Cleared Oct 31, 2008
SONIXTOUCH ULTRASOUND SYSTEM
K083095 · IYN
Ultrasonix Medical Corporation
Radiology · 14d
Cleared Oct 30, 2008
APPLICATORS FOR AFTERLOADING BRACHYTHERAPY
K082530 · JAQ
Isodose Control B.V.
Radiology · 58d
Cleared Oct 28, 2008
DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000
K082798 · KPR
Medicatech USA
Radiology · 35d
Cleared Oct 23, 2008
MEDICAL DISPLAY, MD205MG-1
K082493 · LLZ
Nec Display Solutions , Ltd.
Radiology · 55d
Cleared Oct 22, 2008
RAYDOSE
K082221 · MUJ
Raysearch Laboratories AB
Radiology · 77d
Cleared Oct 22, 2008
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K083001 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 14d
Cleared Oct 21, 2008
SHOWCASE
K082135 · LLZ
Trillium Technology, Inc.
Radiology · 84d
Cleared Oct 17, 2008
P3T ABDOMEN
K082458 · JAK
Medrad, Inc.
Radiology · 52d
Cleared Oct 17, 2008
GE XTREME INJECTOR OPTION
K082960 · JAK
Ge Medical Systems, LLC
Radiology · 14d
Cleared Oct 17, 2008
ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
K083014 · MOS
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Oct 16, 2008
VB IMAGE VIEWER
K080581 · JAK
Olympus Medical Systems Corporation
Radiology · 227d
Cleared Oct 16, 2008
OSDX HIP BMD SYSTEM
K082402 · KGI
Imaging Therapeutics, Inc.
Radiology · 57d
Cleared Oct 15, 2008
XR-EXPRESS
K082336 · LLZ
New Mexico Software, Inc.
Radiology · 62d
Cleared Oct 15, 2008
HRB-127-32 HIGH RESOLUTION BRAIN COIL
K082916 · MOS
Invivo
Radiology · 15d
Cleared Oct 14, 2008
SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100
K082543 · IYO
Sonocine, Inc.
Radiology · 41d
Cleared Oct 14, 2008
4D VIEWER RADIOLOGY, MODEL USWP-100A
K082684 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 29d
Cleared Oct 10, 2008
SOMATOM FLASH DS
K082220 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Oct 10, 2008
PAX-500
K082350 · OAS
VATECH Co., Ltd.
Radiology · 56d
Cleared Oct 10, 2008
CENTERING INTRALUMINAL APPLICATOR
K082653 · JAQ
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Oct 10, 2008
INFX-8000H, INFINIX-I
K082830 · JAA
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Oct 08, 2008
S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE...
K082229 · IYO
Volcano Corporation
Radiology · 62d
Cleared Oct 08, 2008
ZONARE ULTRA ULTRASOUND SYSTEM
K082326 · IYN
Zonare Medical Systems, Inc.
Radiology · 55d