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
6169–6192 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 29, 2011
DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA
K093640 · IXK
Electron Jsco.
Radiology · 521d
Cleared Apr 28, 2011
RENAISSANCE SYSTEM
K110911 · HAW
Mazor Robotics , Ltd.
Radiology · 28d
Cleared Apr 28, 2011
BIOMARC FIDUCIAL MARKER
K110772 · IYE
Carbon Medical Technologies, Inc.
Radiology · 38d
Cleared Apr 28, 2011
SECTRA MICRODOSE MAMMOGRAPHY
K110025 · MUE
Sectra-Imtec AB
Radiology · 115d
Cleared Apr 27, 2011
CUBESCAN / BIOCON-700
K111021 · ITX
Mcube Technology Co., Ltd.
Radiology · 15d
Cleared Apr 27, 2011
UNIVERSAL DIGITAL INTERFACE (UDI) 1717
K103599 · MQB
Meridian Medical Systems, LLC
Radiology · 140d
Cleared Apr 26, 2011
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K110999 · ITX
Edan Instruments, Inc.
Radiology · 15d
Cleared Apr 26, 2011
PRESTODR 4143
K110849 · KPR
Cmt Medical Technologies, Ltd.
Radiology · 29d
Cleared Apr 26, 2011
AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION
K110834 · LLZ
Ge Healthcare
Radiology · 32d
Cleared Apr 21, 2011
JETPACK 2.0
K111024 · LLZ
Philips Medical Systems (Cleveland),...
Radiology · 9d
Cleared Apr 21, 2011
CURVE IMAGE
K110139 · LLZ
Curve Dental, Inc.
Radiology · 93d
Cleared Apr 20, 2011
SYMBIA.NET
K110844 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 23d
Cleared Apr 20, 2011
COMPUTED DENTAL RADIOGRAPHY
K110768 · MUH
Schick Technologies, Inc.
Radiology · 33d
Cleared Apr 20, 2011
SATURN 8000-GS
K110210 · MQB
New Medical Co., Ltd.
Radiology · 85d
Cleared Apr 19, 2011
FLEXIBLE CARDIAC COIL
K110487 · MOS
Lbds Holding Company
Radiology · 56d
Cleared Apr 19, 2011
DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS
K093581 · JAK
Ge Medical Systems, LLC
Radiology · 517d
Cleared Apr 15, 2011
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED...
K110841 · IYN
Shantou Institute of Ultrasonic...
Radiology · 21d
Cleared Apr 15, 2011
ARTISTE SOLUTION WITH SYS_VB50 UPDATE
K103606 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 127d
Cleared Apr 12, 2011
SYNGO.CT CARDIAC FUNCTION
K110366 · JAK
Siemens AG
Radiology · 64d
Cleared Apr 12, 2011
MEDVOXEL HEARTPRO SOFTWARE APPLICATION
K103565 · LLZ
Medvoxel Systems, Inc.
Radiology · 127d
Cleared Apr 08, 2011
UF-760AG
K110920 · ITX
Fukuda Denshi Co., Ltd.
Radiology · 7d
Cleared Apr 08, 2011
A-CHANNELS LUMBAT SPINE COILS 17
K110802 · LNH
Esaote, S.P.A.
Radiology · 16d
Cleared Apr 08, 2011
IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS
K110667 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 30d
Cleared Apr 08, 2011
ATAMA SYSTEM
K110411 · MOS
Monteris Medical, Inc.
Radiology · 53d