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
3625–3648 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 05, 2018
RS85 Diagnostic Ultrasound System
K173204 · IYN
Samsung Medison Co., Ltd.
Radiology · 126d
Cleared Feb 02, 2018
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic...
K173981 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 35d
Cleared Feb 01, 2018
ACUSON P600 Diagnostic Ultrasound System
K180039 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Feb 01, 2018
ACUSON NX3 Diagnostic Ultrasound System
K173957 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 35d
Cleared Jan 31, 2018
Vitrea Software Toshiba Package VSTP-001A
K173088 · LLZ
Toshibamedical Systems Corporation
Radiology · 124d
Cleared Jan 26, 2018
uDR 780i
K173953 · KPR
Shanghai United Imaging Healthcare...
Radiology · 30d
Cleared Jan 26, 2018
SyMRI
K173558 · LNH
Syntheticmr AB
Radiology · 70d
Cleared Jan 26, 2018
Vantage Galan 3T, V4.6
K173382 · LNH
Toshibamedical Systems Corporation
Radiology · 88d
Cleared Jan 26, 2018
DRAGON X SPSL4HC, DRAGON X SPSL8HC
K173299 · IZL
Sedecal., Sa.
Radiology · 101d
Cleared Jan 25, 2018
Arterys Oncology DL
K173542 · LLZ
Arterys, Inc.
Radiology · 70d
Cleared Jan 24, 2018
Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)
K171528 · IYO
Avantsonic Technology Co., Ltd.
Radiology · 244d
Cleared Jan 22, 2018
3D APT
K172920 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 119d
Cleared Jan 19, 2018
PreXion3D Excelsior
K173878 · OAS
Prexion Corporation
Radiology · 29d
Cleared Jan 19, 2018
OnSight 3D Extremity System
K173478 · JAK
Carestream Health, Inc.
Radiology · 67d
Cleared Jan 17, 2018
ARIA Radiation Therapy Management
K173838 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Jan 16, 2018
CS Imaging
K173622 · LLZ
Trophy
Radiology · 53d
Cleared Jan 16, 2018
Navigo Workstation Version 2.0
K173054 · LLZ
UC-CARE , Ltd.
Radiology · 110d
Cleared Jan 12, 2018
GU60A & GU60A-65
K173828 · KPR
Samsung Electronics Co., Ltd.
Radiology · 25d
Cleared Jan 12, 2018
syngo.via RT Image Suite
K173635 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Jan 12, 2018
Optima XR240amx, AutoGrid
K173602 · IZL
Ge Medical Systems, LLC
Radiology · 52d
Cleared Jan 12, 2018
Illumeo System
K173588 · LLZ
Philips Medical Systems Technologies...
Radiology · 53d
Cleared Jan 12, 2018
ImagenUniversal
K173547 · KPS
Cardiovascular Imaging Technologies
Radiology · 57d
Cleared Jan 12, 2018
6440 Ultrasound System
K173291 · IYN
Esaote, S.P.A.
Radiology · 88d
Cleared Jan 11, 2018
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4
K173090 · IYN
Toshibamedical Systems Corporation
Radiology · 104d