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
6721–6744 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 23, 2009
BRILLIANCE DUAL ENERGY OPTION
K090462 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 120d
Cleared Jun 23, 2009
VISION TOOLS
K090668 · LLZ
Millensys
Radiology · 102d
Cleared Jun 23, 2009
PORTALVISION ADVANCED IMAGING
K091209 · IYE
Varian Medical Systems, Inc.
Radiology · 60d
Cleared Jun 22, 2009
DEXIS SOFTWARE
K090431 · LLZ
Dexis, LLC
Radiology · 123d
Cleared Jun 22, 2009
CERNER PROVISION WORKSTATION (VERSION 2.5)
K091032 · LLZ
Cerner Corp.
Radiology · 73d
Cleared Jun 19, 2009
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K091680 · ITX
Edan Instruments, Inc.
Radiology · 9d
Cleared Jun 18, 2009
ARTIS ZEE / ZEEGOS WITH SW VC14
K090745 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Jun 18, 2009
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K091492 · MUJ
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Jun 18, 2009
CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM
K091518 · IYO
Mcube Technology Co., Ltd.
Radiology · 27d
Cleared Jun 18, 2009
MUCHECK V8
K091602 · IYE
Oncology Data Systems, Inc.
Radiology · 15d
Cleared Jun 18, 2009
OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III
K091669 · LNH
Xioao Mdt Technology Co, Ltd.
Radiology · 9d
Cleared Jun 17, 2009
4D INTEGRATED TREATMENT CONSOLE
K091132 · IYE
Varian Medical Systems
Radiology · 58d
Cleared Jun 15, 2009
ONCENTRA SIMULATION 2.3
K090706 · KPQ
Nucletron Corporation
Radiology · 90d
Cleared Jun 15, 2009
GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS
K091103 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 60d
Cleared Jun 15, 2009
DIGITAL RADIOGRAPHY CXDI-60C
K091545 · MQB
Canon, Inc.
Radiology · 19d
Cleared Jun 08, 2009
MODIFICATION TO NORDICICE SOFTWARE
K090546 · LLZ
Nordicimaginglab AS
Radiology · 98d
Cleared Jun 05, 2009
VITREA ENDOVASCULAR STENT PLANNING SOFTWARE
K091498 · LLZ
Vital Images, Inc.
Radiology · 16d
Cleared Jun 04, 2009
R2 DIGITALNOW HD(DIGITALNOW HD)
K091368 · LLZ
Hologic, Inc.
Radiology · 27d
Cleared Jun 02, 2009
I-MAX TOUCH
K083057 · MUH
Owandy
Radiology · 231d
Cleared Jun 02, 2009
X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
K083917 · OAS
Suni Medical Imaging, Inc.
Radiology · 154d
Cleared May 29, 2009
DIGITAL RADIOGRAPHY MODEL CXDI-55G
K091435 · MQB
Canon, Inc.
Radiology · 15d
Cleared May 29, 2009
DIGITAL RADIOGRAPHY, MODEL CXDI-55C
K091436 · MQB
Canon, Inc.
Radiology · 15d
Cleared May 28, 2009
DEXIS SENSOR
K090458 · MUH
Dexis, LLC
Radiology · 94d
Cleared May 27, 2009
RIC CONFORMAL SOURCE, MODEL 100
K090321 · ONL
Ri Consultants, LLC
Radiology · 107d