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
5737–5760 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 01, 2012
SYNAPSE 3D NODULE ANALYSIS
K120679 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 87d
Cleared Jun 01, 2012
VANTAGE TITAN
K120638 · LNH
Toshibamedical Systems Corporation
Radiology · 92d
Cleared May 31, 2012
GUIDEMIA
K121466 · LLZ
Guidemia Technologies, LLC
Radiology · 14d
Cleared May 31, 2012
SPECTRUM V.0
K121023 · LLZ
Intrinsic Medical Imaging
Radiology · 57d
Cleared May 30, 2012
SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE
K120882 · IYO
Bard Access Systems, Inc.
Radiology · 68d
Cleared May 30, 2012
SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM
K113739 · LLZ
Materialise Dental NV
Radiology · 162d
Cleared May 24, 2012
MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS...
K121239 · LNH
Optoacoustics, Ltd.
Radiology · 30d
Cleared May 24, 2012
PAX-DUO3D PLUS, PCT-5000
K121236 · OAS
VATECH Co., Ltd.
Radiology · 30d
Cleared May 24, 2012
LEKSELL GAMMA KNIFE PERFEXION
K120811 · IWB
Elekta Instrument AB
Radiology · 69d
Cleared May 23, 2012
MYLABSOGNO
K121384 · IYN
Esaote, S.P.A.
Radiology · 15d
Cleared May 23, 2012
AERODR X70
K121109 · KPR
Konica Minolta Medical & Graphic, Inc.
Radiology · 41d
Cleared May 23, 2012
SOMATOM DEFINITION EDGE
K120579 · JAK
Siemens Medical Systems, Inc.
Radiology · 86d
Cleared May 23, 2012
VANTAGE TITAN 3T
K120487 · LNH
Toshibamedical Systems Corporation
Radiology · 96d
Cleared May 23, 2012
SOMATOM PERSPECTIVE
K113287 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 198d
Cleared May 22, 2012
UNIVERSAL DIGITAL INTERFACE (UDI) 1717
K112527 · MQB
Meridian Medical Systems, LLC
Radiology · 265d
Cleared May 22, 2012
VIEWRAY SYSTEM
K111862 · IYE
Viewray, Incorporated
Radiology · 327d
Cleared May 17, 2012
ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM
K121138 · IYN
Siemens Medical Solution
Radiology · 34d
Cleared May 17, 2012
MRI SYTEMS
K113281 · LNH
Shenzhen Anke High-Tech Co., Ltd.
Radiology · 192d
Cleared May 15, 2012
QLAB WITH FHN AND VPQ PLUG-IN
K121223 · LLZ
Philips Ultrasound, Inc.
Radiology · 22d
Cleared May 10, 2012
EZSENSOR P DIGITAL INTRAORAL SENSOR
K121132 · MQB
Humanray Co,Ltd
Radiology · 27d
Cleared May 08, 2012
SOMATOM DEFINITION FLASH
K121072 · JAK
Siemens Medical Systems, Inc.
Radiology · 29d
Cleared May 08, 2012
SYNAPSE 3D BRAIN PERFUSION
K120637 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 68d
Cleared May 07, 2012
APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM
K120106 · MUH
Apixia, Inc.
Radiology · 115d
Cleared May 07, 2012
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW,...
K113732 · JAK
Brainlab AG
Radiology · 140d