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
6745–6768 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 01, 2009
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K091146 · MUJ
Accuray, Inc.
Radiology · 11d
Cleared Apr 30, 2009
IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM
K090059 · IYO
Saset (Chengdu), Inc.
Radiology · 111d
Cleared Apr 30, 2009
COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D
K090171 · OAS
E-Woo Technology
Radiology · 97d
Cleared Apr 28, 2009
SYNGO BREVIS
K090038 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 112d
Cleared Apr 24, 2009
ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL...
K090178 · KPS
Neusoft Positron Medical Systems Co.,...
Radiology · 88d
Cleared Apr 22, 2009
SPEC MODEL M-31
K090366 · KXK
Source Production & Equipment Co., Inc.
Radiology · 68d
Cleared Apr 22, 2009
BARCO 5MP MAMMO, MODEL MDMG-5221
K090603 · LLZ
Barco N.V.
Radiology · 48d
Cleared Apr 22, 2009
BLUE SKY BIO PLAN, VERSION .38
K090607 · LLZ
Blue Sky Bio, LLC
Radiology · 47d
Cleared Apr 20, 2009
NIO COLOR 3MP AND MDNC-3121
K090732 · LLZ
Barco N.V.
Radiology · 32d
Cleared Apr 15, 2009
IBA PROTON THERAPY SYSTEM - PROTEUS 235
K083058 · LHN
Ion Beam Applications S.A.
Radiology · 183d
Cleared Apr 15, 2009
VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW,...
K083910 · LLZ
Vidistar, LLC
Radiology · 106d
Cleared Apr 15, 2009
MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL
K090215 · LLZ
Nec Display Solutions , Ltd.
Radiology · 76d
Cleared Apr 15, 2009
MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ
K090218 · LLZ
Nec Display Solutions , Ltd.
Radiology · 76d
Cleared Apr 15, 2009
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900
K090912 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 14d
Cleared Apr 13, 2009
P.D SOFTWARE
K083672 · MUJ
.Decimal, Inc.
Radiology · 123d
Cleared Apr 10, 2009
I OPEN 0.5T
K090873 · LNH
Beijing Wandong Medical Equipment...
Radiology · 10d
Cleared Apr 08, 2009
DIGDOP ULTRASOUND SYSTEM
K090465 · ITX
The Newman Group, LLC
Radiology · 44d
Cleared Apr 06, 2009
CARESTREAM DRX-1 SYSTEM
K090318 · MQB
Carestream Health, Inc.
Radiology · 56d
Cleared Apr 03, 2009
INFANT CARDIAC ARRAY
K083539 · MOS
Advanced Imaging Research, Inc.
Radiology · 126d
Cleared Apr 03, 2009
YIELD MINI DOPPLER SYSTEM
K090743 · IYN
Broncus Technologies, Inc.
Radiology · 14d
Cleared Apr 03, 2009
PINNACLE3 SMARTARC
K090808 · MUJ
Philips Medical Systems, Inc.
Radiology · 9d
Cleared Apr 01, 2009
SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY
K083524 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 124d
Cleared Mar 31, 2009
ACUSON P50 ULTRASOUND SYSTEM
K083114 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 161d
Cleared Mar 31, 2009
CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING
K083446 · LLZ
Ziosoft, Inc.
Radiology · 130d