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
3649–3672 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 11, 2018
DTX Studio diagnose
K172224 · LLZ
Nobel Biocare AB
Radiology · 170d
Cleared Jan 11, 2018
ECHELON OVAL V6.0A MRI System
K172110 · LNH
Hitachi Healthcare Americas Corporation
Radiology · 182d
Cleared Jan 09, 2018
16ch T/R Hand Wrist Coil
K173469 · MOS
Quality Electrodynamics, LLC
Radiology · 62d
Cleared Jan 09, 2018
Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems
K173021 · IYN
Supersonic Imagine
Radiology · 103d
Cleared Jan 09, 2018
Ultra/Phonic Free Conductivity Gel
K163027 · MUI
Pharmaceutical Innovations, Inc.
Radiology · 435d
Cleared Jan 09, 2018
Ultra/Phonic Scanning Gel
K163026 · MUI
Pharmaceutical Innovations, Inc.
Radiology · 435d
Cleared Jan 08, 2018
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic
K173471 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 61d
Cleared Jan 08, 2018
cNeuro cMRI
K171328 · LLZ
Combinostics OY
Radiology · 248d
Cleared Jan 08, 2018
Ultra/Phonic Conductivity Gel
K163024 · MUI
Pharmaceutical Innovations, Inc.
Radiology · 434d
Cleared Jan 08, 2018
Other-Sonic Transmission Gel
K163023 · MUI
Pharmaceutical Innovations, Inc.
Radiology · 434d
Cleared Jan 05, 2018
ViewPoint 6
K173456 · LLZ
Ge Medical Systems Ultrasound and...
Radiology · 59d
Cleared Jan 02, 2018
Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound...
K172860 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 104d
Cleared Jan 02, 2018
Clover 50/Clover60/Clover70 Diagnostic Ultrasound System
K163712 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 368d
Cleared Dec 29, 2017
Medtronic O-arm O2 Imaging System
K173664 · OWB
Medtronic, Inc.
Radiology · 30d
Cleared Dec 28, 2017
Planmed Clarity
K163328 · MUE
Planmed OY
Radiology · 395d
Cleared Dec 27, 2017
Radiomics App v1.0
K173420 · LLZ
Microsoft Corp.
Radiology · 56d
Cleared Dec 27, 2017
MEVION S250i Proton Beam Radiation Therapy Device
K172848 · LHN
Mevion Medical Systems
Radiology · 99d
Cleared Dec 26, 2017
Real Time Image Gating System for Proton Beam Therapy Systems
K171049 · LHN
Hitachi, Ltd. Healthcare
Radiology · 263d
Cleared Dec 22, 2017
GammaPod - Model A
K172706 · IWB
Xcision Medical Systems, LLC
Radiology · 106d
Cleared Dec 20, 2017
Biograph mCT Family of PET/CT Systems
K173578 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Dec 20, 2017
LOGIQ E10
K173555 · IYN
Ge Healthcare
Radiology · 33d
Cleared Dec 19, 2017
FS Ergo
K173646 · MUH
Palodex Group OY
Radiology · 22d
Cleared Dec 19, 2017
MAGNETOM Amira
K173600 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Dec 19, 2017
LumiCoil Platinum Fiducial Marker
K173251 · IYE
Boston Scientific Corporation
Radiology · 70d