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
4009–4032 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 19, 2017
TrueBeam-TrueBeam STx-Edge
K162472 · IYE
Varian Medical Systems, Inc.
Radiology · 135d
Cleared Jan 18, 2017
Breast BI 7 MR Coil Mammavention 3T
K162651 · MOS
Moras Mri Products GmbH
Radiology · 117d
Cleared Jan 13, 2017
RX DC
K163519 · EHD
Cefla S.C.
Radiology · 29d
Cleared Jan 12, 2017
ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems
K163635 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 21d
Cleared Jan 12, 2017
EzDent-i
K163533 · LLZ
Ewoosoft Co., Ltd.
Radiology · 27d
Cleared Jan 12, 2017
48CH Head Coil
K163205 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 58d
Cleared Jan 10, 2017
Mammomat Fusion with Stereotactic Biopsy
K163252 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared Jan 10, 2017
EPIQ 5 Diagnostic Ultrasound System
K163120 · IYN
Philips Ultrasound, Inc.
Radiology · 63d
Cleared Jan 09, 2017
Sentinel BreastScan II System
K162767 · LHQ
First Sense Medical, LLC
Radiology · 101d
Cleared Jan 09, 2017
Symbia Intevo Bold
K162483 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Jan 09, 2017
Bindex BI-2
K161971 · MUA
Bone Index Finland , Ltd.
Radiology · 175d
Cleared Jan 09, 2017
D2P
K161841 · LLZ
3D Systems, Inc.
Radiology · 188d
Cleared Jan 06, 2017
Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
K163116 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 60d
Cleared Jan 06, 2017
Quantib Brain 1.2
K163013 · LLZ
Quantib B.V.
Radiology · 70d
Cleared Jan 06, 2017
8ch Knee-Foot SPEEDER
K162946 · MOS
Quality Electrodynamics, LLC
Radiology · 77d
Cleared Jan 06, 2017
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
K162931 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 79d
Cleared Jan 05, 2017
Arterys Cardio DL
K163253 · LLZ
Arterys, Inc.
Radiology · 48d
Cleared Jan 04, 2017
B6
K163429 · OXO
Beijing East Whale Imaging Technology...
Radiology · 28d
Cleared Jan 04, 2017
DigitalDiagnost C50
K163410 · KPR
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 30d
Cleared Jan 04, 2017
ACUSON P500 Ultrasound System
K163396 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Jan 04, 2017
CephSimulation
K161270 · LLZ
Anatomage, Inc.
Radiology · 244d
Cleared Jan 03, 2017
X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System
K163427 · IYN
Sonoscape Medical Corp.
Radiology · 28d
Cleared Jan 03, 2017
syngo.via MI Workflows
K163421 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Dec 30, 2016
MultiBand SENSE
K162940 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 70d