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
4513–4536 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 26, 2015
Volpara Imaging Software
K152028 · LLZ
Matakina Technologies Limited
Radiology · 96d
Cleared Oct 26, 2015
Varian Treatment (VTx)
K151882 · IYE
Varian Medical Systems, Inc.
Radiology · 109d
Cleared Oct 23, 2015
Vantage Titan 3T
K152371 · LNH
Toshibamedical Systems Corporation
Radiology · 63d
Cleared Oct 23, 2015
Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart
K152106 · OAS
VATECH Co., Ltd.
Radiology · 86d
Cleared Oct 21, 2015
MHI-TM2000 Linear Accelerator System, VERO, Imavis
K152867 · IYE
Mitsubishi Heavy Industries, Ltd.
Radiology · 21d
Cleared Oct 21, 2015
EOS System
K152788 · KPR
Eos Imaging
Radiology · 26d
Cleared Oct 21, 2015
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound...
K152763 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 27d
Cleared Oct 21, 2015
EVS 3643
K151942 · MQB
DRTECH Corporation
Radiology · 99d
Cleared Oct 16, 2015
GR40CW
K152094 · MQB
Samsung Electronics Co., Ltd.
Radiology · 80d
Cleared Oct 16, 2015
Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic...
K150037 · JAD
Sensus Healthcare
Radiology · 280d
Cleared Oct 15, 2015
Visible Patient Suite
K151988 · LLZ
Visible Patient, Sas
Radiology · 90d
Cleared Oct 15, 2015
MrOpen
K151466 · LNH
Paramed S.R.L.
Radiology · 136d
Cleared Oct 10, 2015
Vitrea CT Lung Density Analysis Software
K151919 · JAK
Vital Images, Inc.
Radiology · 89d
Cleared Oct 10, 2015
D2RS_AT Digital Dynamic Remote System
K150306 · JAA
Stephanix Radiological Solutions
Radiology · 243d
Cleared Oct 09, 2015
SOMATOM Definition Edge, SOMATOM Definition AS/AS+
K152036 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Oct 09, 2015
Aquilion Lightning (TSX-035A/2, V7.0)
K151833 · JAK
Toshibamedical Systems Corporation
Radiology · 95d
Cleared Oct 08, 2015
ULTRASOUND SYSTEM SONIMAGE HS 1
K152577 · IYN
Konica Minolta, Inc.
Radiology · 29d
Cleared Oct 07, 2015
DEXIS Webview
K151941 · LLZ
Imaging Sciences International...
Radiology · 85d
Cleared Oct 06, 2015
ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System
K152369 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 46d
Cleared Oct 05, 2015
Ultrasound Scanner System BK2300
K151910 · IYN
Bk Medical Aps
Radiology · 84d
Cleared Oct 05, 2015
CygneX I System
K143560 · IYE
Accuthera, Inc.
Radiology · 293d
Cleared Oct 05, 2015
ADX6000 Portable X-Ray System
K143494 · IZL
Dexcowin Co., Ltd.
Radiology · 300d
Cleared Oct 02, 2015
DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems
K152545 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 24d
Cleared Oct 02, 2015
Extended Range Shifter for PROBEAT-V
K152207 · LHN
Hitachi, Ltd., Health Care Company
Radiology · 57d