FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
4681–4704 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 07, 2015
UltraVision 2 Diagnostic Ultrasound System
K150580 · IYO
Winprobe Corporation
Radiology · 29d
Cleared Apr 06, 2015
VitreaView
K150738 · LLZ
Vital Images, Inc.
Radiology · 17d
Cleared Apr 06, 2015
SOMATOM Definition Edge
K143401 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 129d
Cleared Apr 06, 2015
Ziehm Vision RFD 3D
K142740 · OWB
Ziehm Imaging GmbH
Radiology · 194d
Cleared Apr 03, 2015
2MP Color LCD Monitor, RadiForce RS240
K150106 · PGY
Eizo Corporation
Radiology · 73d
Cleared Apr 02, 2015
EzDent-i /E2/Prora View
K150747 · LLZ
LK Consulting Group USA, Inc.
Radiology · 10d
Cleared Apr 02, 2015
GC85A
K150165 · KPR
Samsung Electronics Co., Ltd.
Radiology · 66d
Not Cleared Apr 01, 2015
SpaceOAR System
DEN140030 · OVB
Augmenix, Inc.
Radiology · 182d
Cleared Mar 31, 2015
Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301
K150234 · PCT
Myriad Medical, LLC
Radiology · 57d
Cleared Mar 30, 2015
Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System
K150529 · IYO
C.R. Bard, Inc.
Radiology · 28d
Cleared Mar 29, 2015
Scenium
K150192 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 60d
Cleared Mar 27, 2015
1717SGN / 1717SCN Digital Flat Panel X-ray Detector
K150150 · MQB
Rayence Co., Ltd.
Radiology · 63d
Cleared Mar 27, 2015
Patient Positioning Devices
K142420 · IYE
Macromedics BV
Radiology · 211d
Cleared Mar 26, 2015
A35 Diagnostic Ultrasound System
K150478 · IYN
Samsung Medison Co., Ltd.
Radiology · 30d
Cleared Mar 26, 2015
SOMATOM Definition AS Open (VA48)
K143409 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 118d
Cleared Mar 26, 2015
Mammo Workstation
K143361 · LLZ
Ge Healthcare
Radiology · 122d
Cleared Mar 26, 2015
FlexiMarc Marker
K142294 · IYE
Cortex Manufacturing, Inc.
Radiology · 220d
Cleared Mar 24, 2015
Customer Remote Console (CRC)
K150193 · LLZ
Ge Medical Systems, LLC
Radiology · 55d
Cleared Mar 20, 2015
Volcano iFR Modality, iFR Scout feature
K150441 · IYO
Volcano Corporation
Radiology · 28d
Cleared Mar 20, 2015
mDIXON XD
K143128 · LNH
Philips Medical Systems Nederlands B.V.
Radiology · 141d
Cleared Mar 19, 2015
Aquilion LB, TSX-201A/3, V6.0
K150003 · JAK
Toshibamedical Systems Corporation
Radiology · 76d
Cleared Mar 19, 2015
Blackford Analysis Registration Product Family
K142337 · LLZ
Blackford Analysis, Ltd.
Radiology · 210d
Cleared Mar 18, 2015
NICAL SMART MICRO CR system for intraoral dental images
K143703 · MUH
Nical Spa
Radiology · 79d
Cleared Mar 18, 2015
U-Lite
K143601 · IYN
Sonoscanner Sarl
Radiology · 90d