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
3817–3840 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 15, 2017
Eclipse Treatment Planning System
K172163 · MUJ
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Aug 10, 2017
OEC Elite
K171565 · OWB
Ge Oec Medical Systems, Inc.
Radiology · 72d
Cleared Aug 10, 2017
SmartUs EXT-1M/3M
K163121 · IYN
Telemed
Radiology · 275d
Cleared Aug 09, 2017
WS80A Diagnostic Ultrasound System
K171070 · IYN
Samsung Medison Co., Ltd.
Radiology · 121d
Cleared Aug 08, 2017
HS40 Diagnostic Ultrasound System
K172129 · IYN
Samsung Medison Co., Ltd.
Radiology · 25d
Cleared Aug 03, 2017
Clarity Reveal
K171356 · LLZ
Ceevra, Inc.
Radiology · 86d
Cleared Aug 03, 2017
U-Lite EXP
K171164 · IYN
Sonoscanner
Radiology · 105d
Cleared Jul 31, 2017
Scanmate Flex
K171301 · IYO
Dgh Technology, Inc.
Radiology · 89d
Cleared Jul 31, 2017
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD...
K171040 · ITX
Koelis
Radiology · 116d
Cleared Jul 28, 2017
VitalBeam
K172013 · IYE
Varian Medical Systems, Inc.
Radiology · 25d
Cleared Jul 28, 2017
NovaPACS
K171754 · LLZ
Novarad Corporation
Radiology · 45d
Cleared Jul 28, 2017
Smart Stitching Software System, Image Processing, Radiological
K163048 · LLZ
Osko, Inc.
Radiology · 269d
Cleared Jul 26, 2017
NHAC 16
K171515 · MOS
Lmt Medical Systems GmbH
Radiology · 63d
Cleared Jul 26, 2017
BiopSee, Mobile US
K170841 · LLZ
Medcom GmbH
Radiology · 127d
Cleared Jul 25, 2017
Radiance V4
K171885 · MUJ
Gmv Soluciones Globales Internet S.A.U.
Radiology · 29d
Cleared Jul 25, 2017
TomoTherapy Treatment Delivery System with iDMS
K171837 · IYE
Accuray Incorporated
Radiology · 35d
Cleared Jul 25, 2017
HP PRO Positioning Device
K171734 · IYE
Orfit Industries NV
Radiology · 43d
Cleared Jul 24, 2017
YELLOW 560 Fluorescence Module
K162991 · IZI
Carl Zeiss Meditec, AG
Radiology · 270d
Cleared Jul 21, 2017
Vantage Elan 1.5T, V4.0
K171597 · LNH
Toshibamedical Systems Corporation
Radiology · 51d
Cleared Jul 21, 2017
Ultimax-i, DREX-UI80 V1.60
K170832 · OWB
Toshibamedical Systems Corporation
Radiology · 123d
Cleared Jul 21, 2017
Vitrea View
K163232 · LLZ
Vital Images, Inc.
Radiology · 246d
Cleared Jul 19, 2017
Nio Color 2MP (MDNC-2123)
K171812 · PGY
Barco N.V.
Radiology · 30d
Cleared Jul 19, 2017
Embrace Neonatal MRI System
K170978 · LNH
Aspect Imaging, Ltd.
Radiology · 107d
Cleared Jul 19, 2017
OLINDA EXM
K163687 · IYX
Hermes Medical Solutions AB
Radiology · 203d