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
4705–4728 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 09, 2015
18ch T/R Knee Coil
K150331 · MOS
Quality Electrodynamics, LLC
Radiology · 58d
Cleared Apr 09, 2015
O-MAR
K143253 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 147d
Cleared Apr 09, 2015
Vantage Titan 3T
K143008 · LNH
Toshibamedical Systems Corporation
Radiology · 171d
Cleared Apr 09, 2015
G-scan Brio
K142421 · LNH
Esaote, S.P.A.
Radiology · 224d
Cleared Apr 09, 2015
Kobold Ring and Tandem Applicator Set
K142330 · JAQ
Kobold, LLC
Radiology · 232d
Cleared Apr 08, 2015
ELIAN Digital Diagnostic X-ray System
K150506 · KPR
Osko, Inc.
Radiology · 41d
Cleared Apr 08, 2015
SOMATOM Definition AS/AS+
K143400 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 131d
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