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
5977–6000 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 18, 2011
MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM
K110596 · LLZ
Wide Corporation
Radiology · 261d
Cleared Nov 15, 2011
SONOSITE EDGE ULTRASOUND SYSTEM
K113156 · IYO
Sonosite,Inc.
Radiology · 20d
Cleared Nov 14, 2011
VARIAN HIGH ENERGY LINEAR ACCELERATOR
K112839 · IYE
Varian Medical Systems
Radiology · 47d
Cleared Nov 10, 2011
CT-GUIDE NEEDLE GUIDANCE SYSTEM
K113063 · JAK
Activiews, Ltd.
Radiology · 27d
Cleared Nov 10, 2011
DIGITAL FLAT PANEL X-RAY DETECTOR
K112558 · MQB
Samsung Mobile Display Co., Ltd.
Radiology · 69d
Cleared Nov 07, 2011
S6 DIAGNOSTIC ULTRASOUND SYSTEM
K112602 · IYN
Sonoscape Company Limited
Radiology · 61d
Cleared Nov 07, 2011
MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2
K112145 · LLZ
Totoku Electric Co., Ltd.
Radiology · 104d
Cleared Nov 04, 2011
PERFSCAPE V2.0
K111161 · LLZ
Olea Medical
Radiology · 193d
Cleared Nov 04, 2011
FXA (TM)
K110765 · LLZ
Aces GmbH
Radiology · 231d
Cleared Nov 01, 2011
EUS BALLOON
K111028 · FDF
United States Endoscopy Group, Inc.
Radiology · 202d
Cleared Nov 01, 2011
UC-CARE NAVIGO SYTEM
K100784 · LLZ
UC-CARE , Ltd.
Radiology · 592d
Cleared Oct 27, 2011
FETAL DOPPLER
K112911 · KNG
Beijing Choice Electronic Technololgy...
Radiology · 24d
Cleared Oct 27, 2011
DX-D 600
K112670 · KPR
Agfa Healthcare N.V.
Radiology · 43d
Cleared Oct 27, 2011
21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)
K112604 · LLZ
Totoku Electric Co., Ltd.
Radiology · 50d
Cleared Oct 27, 2011
TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER
K112529 · KNG
Advanced Instrumentations, Inc.
Radiology · 57d
Cleared Oct 27, 2011
4MP COLOR LCD MONITOR, RADIFORCERX430
K112466 · LLZ
Eizo Nanao Corporation
Radiology · 62d
Cleared Oct 27, 2011
GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L
K111434 · MUE
Giotto USA, LLC
Radiology · 157d
Cleared Oct 20, 2011
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K112974 · LLZ
Curve Dental, Inc.
Radiology · 15d
Cleared Oct 20, 2011
VIZION DR
K112661 · MQB
Viztek, LLC
Radiology · 37d
Cleared Oct 20, 2011
CARESTREAM PACS
K110919 · LLZ
Carestream Health, Inc.
Radiology · 202d
Cleared Oct 20, 2011
DIGIVIEW 250
K103348 · MQB
Kub Technologies, Inc.
Radiology · 339d
Cleared Oct 18, 2011
RADIOACTIVE SEED LOCALIZATION NEEDLE
K111979 · KXK
Biocompatibles, Inc.
Radiology · 98d
Cleared Oct 17, 2011
SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0
K112439 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 54d
Cleared Oct 17, 2011
CORONIS 5MP
K111990 · LLZ
Barco N.V.
Radiology · 96d