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
4417–4440 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 04, 2016
ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray
K152489 · OAS
Panoramic Corp.
Radiology · 156d
Cleared Feb 03, 2016
Synapse PACS
K160108 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 15d
Cleared Feb 03, 2016
Adaptivo
K152994 · IYE
Aurora Technology Development, LLC
Radiology · 113d
Cleared Feb 02, 2016
WS80A Diagnostic Ultrasound System
K153529 · IYN
Samsung Medison Co., Ltd.
Radiology · 55d
Cleared Feb 02, 2016
ArcScan Insight 100
K153416 · IYO
Arcscan, Inc.
Radiology · 69d
Cleared Feb 02, 2016
HF1202H PowerPlus Portable X-ray Equipment
K153059 · IZL
Minxray, Inc.
Radiology · 104d
Cleared Jan 29, 2016
SD5 & SD6 Ultrasonic Tabletop Doppler
K153475 · KNG
Edan Instruments, Inc.
Radiology · 58d
Cleared Jan 29, 2016
ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+
K151426 · IYE
Scandidos AB
Radiology · 246d
Cleared Jan 25, 2016
Fusion Bx
K153166 · LLZ
Focal Healtcare, Inc.
Radiology · 84d
Cleared Jan 25, 2016
DG PACS
K152977 · LLZ
Dicom Grid, Inc.
Radiology · 109d
Cleared Jan 25, 2016
ImagenSPECT
K152503 · KPS
Cardiovascular Imaging Technologies
Radiology · 145d
Cleared Jan 21, 2016
HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS
K153421 · IYN
Hitachi Aloka Medical America, Inc.
Radiology · 57d
Cleared Jan 21, 2016
Discovery NM/CT 670 CZT
K153402 · KPS
Ge Healthcare
Radiology · 58d
Cleared Jan 20, 2016
SonoSite Edge II Ultrasound System
K153626 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 33d
Cleared Jan 20, 2016
Stroke VCAR
K152584 · JAK
GE Medical Systems SCS
Radiology · 132d
Cleared Jan 20, 2016
CAS-One IR
K152473 · JAK
Cascination AG
Radiology · 142d
Cleared Jan 20, 2016
Stereo 3D option for Vision Applications
K152352 · LLZ
GE Medical Systems SCS
Radiology · 153d
Cleared Jan 15, 2016
HEALTHMYNE
K153289 · LLZ
Healthmyne, Inc.
Radiology · 63d
Cleared Jan 15, 2016
INFX-8000C, V6.20
K152697 · OWB
Toshibamedical Systems Corporation
Radiology · 116d
Cleared Jan 15, 2016
BR-ABVS Viewer 1.0
K151075 · LLZ
Taihao Medical, Inc.
Radiology · 268d
Cleared Jan 13, 2016
S50 Digital Color Doppler Ultrasound System
K152854 · IYN
Sonoscape Medical Corp.
Radiology · 106d
Cleared Jan 13, 2016
Sonishield 100 Antimicrobial Ultrasound Gel
K151070 · MUI
Quotient Medical
Radiology · 267d
Cleared Jan 12, 2016
3MP Color LCD Monitor, RadiForce RX350
K153354 · PGY
Eizo Corporation
Radiology · 53d
Cleared Jan 12, 2016
Cios Connect
K153147 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 74d