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
3601–3624 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 23, 2018
DM-Density
K170540 · LLZ
Densitas, Inc.
Radiology · 365d
Cleared Feb 20, 2018
WS80A Diagnostic Ultrasound System
K173513 · IYN
Samsung Medison Co., Ltd.
Radiology · 99d
Cleared Feb 16, 2018
Breast BI 7 MR Coil 1.5T Mammavention
K180123 · MOS
Noras Mri Products GmbH
Radiology · 31d
Cleared Feb 16, 2018
Wireless Audio System
K173409 · LNH
Neocoil, LLC
Radiology · 107d
Cleared Feb 15, 2018
Velocity
K173636 · LLZ
Varian Medical Systems, Inc.
Radiology · 83d
Cleared Feb 13, 2018
MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM...
K173592 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Feb 13, 2018
CT6485, CT12885
K172058 · JAK
Analogic Corporation
Radiology · 222d
Not Cleared Feb 13, 2018
ContaCT
DEN170073 · QAS
Viz.Al, Inc.
Radiology · 137d
Cleared Feb 12, 2018
SuRgical Planner (SRP)
K170793 · LLZ
Surgical Theater, LLC
Radiology · 333d
Cleared Feb 09, 2018
Amrad Medical AAU Digital Radiography System
K173823 · KPR
Summit Industries, LLC
Radiology · 53d
Cleared Feb 09, 2018
Leksell GammaPlan
K173791 · IWB
Elekta Instrument AB
Radiology · 57d
Cleared Feb 09, 2018
OSCAR 15
K172180 · OWB
Genoray Co., Ltd.
Radiology · 205d
Cleared Feb 09, 2018
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy...
K171755 · OWB
Omega Medical Imaging, LLC
Radiology · 241d
Cleared Feb 09, 2018
Standard Catheter Set
K171631 · JAQ
Varian Medical Systems, Inc.
Radiology · 252d
Cleared Feb 08, 2018
UNiD Spine Analyzer
K180091 · LLZ
Medicrea International
Radiology · 27d
Cleared Feb 08, 2018
Ultrasound System SONIMAGE MX1
K180084 · IYO
Konica Minolta, Inc.
Radiology · 28d
Cleared Feb 08, 2018
superDimension Navigation System V7.2
K173244 · JAK
Covidien, LLC
Radiology · 125d
Cleared Feb 08, 2018
SENYINT Remote Consultation System
K162727 · LLZ
Dalian Senyint Digital Medical System...
Radiology · 497d
Cleared Feb 07, 2018
ACUSON X800 Diagnostic Ultrasound System
K180067 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Feb 06, 2018
Insight BD
K172832 · LLZ
Siemens Medi Cal Solutions, Inc.
Radiology · 140d
Cleared Feb 06, 2018
eUnity
K172490 · LLZ
Client Outlook, Inc.
Radiology · 173d
Cleared Feb 05, 2018
DRX-Revolution Nano Mobile X-ray System
K173924 · IZL
Carestream Health, Inc.
Radiology · 41d
Cleared Feb 05, 2018
MFI-Cardiac
K173512 · LLZ
Multifunctional Imaging, LLC
Radiology · 84d
Cleared Feb 05, 2018
ProxiDiagnost N90
K173433 · OWB
Philips Medical Systems Dmc GmbH
Radiology · 95d