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
3433–3456 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 18, 2018
ARIETTA 65
K181376 · IYN
Hitachi Healthcare Americas Corporation
Radiology · 55d
Cleared Jul 18, 2018
ACCUSYTE 3D Fiducial Marker
K180027 · IYE
Radiation Products, LLC
Radiology · 196d
Cleared Jul 17, 2018
Cook-Swartz Doppler Flow Probe
K171272 · ITX
Cook Incorporated
Radiology · 442d
Cleared Jul 13, 2018
Aquarius 8600 Digital Radiography Sensor
K181565 · MQB
Biokinemetrics, Inc.
Radiology · 29d
Cleared Jul 11, 2018
16ch Foot/ Ankle SPEEDER
K181697 · MOS
Quality Electrodynamics, LLC
Radiology · 14d
Cleared Jul 11, 2018
Transcranial Doppler Ultrasound System
K173801 · IYN
Shenzhen Delica Medical Equipment...
Radiology · 209d
Cleared Jul 11, 2018
Intelli-C
K173631 · OWB
Nrt X-Ray A/S
Radiology · 229d
Cleared Jul 11, 2018
NTU-USB Ultrasound USB Box
K173486 · IYN
National Taiwan University
Radiology · 240d
Cleared Jul 10, 2018
Uscan
K181574 · IYO
EchoNous, Inc.
Radiology · 25d
Cleared Jul 10, 2018
Workflow Box
K181572 · QKB
Mirada Medical, Ltd.
Radiology · 26d
Cleared Jul 10, 2018
Disposable guides KDNG00
K180970 · ITX
Koelis
Radiology · 88d
Cleared Jul 10, 2018
Pseudo-Patient
K180697 · IYE
Rtsafe, Inc.
Radiology · 116d
Cleared Jul 10, 2018
3D Bolus Software
K180289 · MUJ
3D Bolus, Inc.
Radiology · 159d
Cleared Jul 10, 2018
Ceevra Reveal 2.0
K173274 · LLZ
Ceevra, Inc.
Radiology · 271d
Cleared Jul 09, 2018
FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
K181547 · IYO
Echosens
Radiology · 27d
Cleared Jul 06, 2018
GammaTile
K180515 · KXK
Isoray Medical, Inc.
Radiology · 129d
Cleared Jul 03, 2018
XRpad2 4343 HWC-M Flat Panel Detector
K181526 · MQB
Varex Imaging Corporation
Radiology · 22d
Cleared Jun 29, 2018
Proton Positioing and Immobilization Devices
K180021 · IYE
Medtec Inc Dba Civco Medical...
Radiology · 177d
Cleared Jun 28, 2018
Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator
K181404 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Jun 27, 2018
uDR 592h, uDR 596i
K181413 · KPR
Shanghai United Imaging Healthcare...
Radiology · 28d
Cleared Jun 26, 2018
DenSeeMammo
K173574 · LLZ
Statlife
Radiology · 218d
Cleared Jun 25, 2018
SpaceOAR System
K181465 · OVB
Augmenix, Inc.
Radiology · 21d
Cleared Jun 25, 2018
Vscan Extend
K180995 · IYN
GE Medical Systems Ultrasound and...
Radiology · 70d
Cleared Jun 22, 2018
MIM - SPECTRA Quant
K180815 · LLZ
Mim Software, Inc.
Radiology · 85d