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
6697–6720 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared May 27, 2009
RADCALC SOFTWARE, VERSION 6.0
K090531 · MUJ
Lifeline Software, Inc.
Radiology · 89d
Cleared May 27, 2009
FLEXIPLAN 3D AND 3D+
K091145 · MUJ
Isodose Control B.V.
Radiology · 37d
Cleared May 27, 2009
PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
K091195 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 34d
Cleared May 26, 2009
GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND
K091374 · IYO
Ge Medical Systems China Co., Ltd.
Radiology · 15d
Cleared May 22, 2009
CAAS MR FLOW 1.0
K090155 · LLZ
Pie Medical Imaging BV
Radiology · 120d
Cleared May 22, 2009
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
K090461 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 88d
Cleared May 22, 2009
CARESTREAM DRYVIEW 5850 LASER IMAGER
K090469 · LMC
Carestream Health, Inc.
Radiology · 88d