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
3793–3816 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 13, 2017
NeuViz Prime Multi-slice CT Scanner System
K171201 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 142d
Cleared Sep 12, 2017
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound...
K171233 · IYN
Shenzhen Mindray Bio-Meidcal...
Radiology · 138d
Cleared Sep 07, 2017
NeuroQuant
K170981 · LLZ
Cortechs Labs, Inc.
Radiology · 157d
Cleared Sep 06, 2017
Poseidon Ultrasound System
K163510 · IYN
Butterfly Network, Inc.
Radiology · 265d
Cleared Sep 01, 2017
Senographe Pristina
K163302 · MUE
Ge Healthcare
Radiology · 283d
Cleared Aug 31, 2017
DUS-7000 Digital Color Doppler Ultrasound System
K172055 · IYN
Advanced Instrumentations, Inc.
Radiology · 56d
Cleared Aug 31, 2017
Orthopantomograph OP300
K163423 · OAS
Palodex Group OY
Radiology · 268d
Cleared Aug 31, 2017
Kelowna GYN and Crook Prostate Templates
K162533 · JAQ
Varian Medical Systems, Inc.
Radiology · 356d
Cleared Aug 29, 2017
SyMRI
K162943 · LNH
Syntheticmr AB
Radiology · 312d
Cleared Aug 25, 2017
VMA™ System version 3.0
K172327 · LLZ
Ortho Kinematics, Inc.
Radiology · 24d
Cleared Aug 25, 2017
SKR 3000
K171716 · MQB
Konica Minolta, Inc.
Radiology · 77d
Cleared Aug 25, 2017
Sirius MRI Marker NS
K171487 · KXK
C4 Imaging, LLC
Radiology · 95d
Cleared Aug 24, 2017
RS80A Diagnostic Ultrasound System
K171048 · IYN
Samsung Medison Co., Ltd.
Radiology · 139d
Cleared Aug 24, 2017
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive...
K170750 · MUJ
Brainlab AG
Radiology · 164d
Cleared Aug 22, 2017
EzDent-i / E2 / Prora View
K172364 · LLZ
Ewoosoft Co., Ltd.
Radiology · 18d
Cleared Aug 22, 2017
OKI Surgical Planning Software
K171617 · LLZ
Ortho Kinematics, Inc.
Radiology · 82d
Cleared Aug 18, 2017
Acclarix AX4 Diagnostic Ultrasound System
K171900 · IYN
Edan Instruments, Inc.
Radiology · 53d
Cleared Aug 18, 2017
Supria True64
K171738 · JAK
Hitachi Healthcare Americas Corporation
Radiology · 67d
Cleared Aug 18, 2017
ScannerSide DoseCheck
K171261 · JAK
Right Dose, Inc.
Radiology · 109d
Cleared Aug 18, 2017
OmniTom
K171183 · JAK
Neurologica Corporation
Radiology · 116d
Cleared Aug 18, 2017
NuVasive LessRay with Enhanced Tracking
K170800 · OWB
Nu Vasive, Incorporated
Radiology · 154d
Cleared Aug 17, 2017
IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus...
K163500 · LHN
Ion Beam Applications S.A.
Radiology · 247d
Cleared Aug 16, 2017
ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems
K172162 · IYN
Siemens Healthcare
Radiology · 29d
Cleared Aug 15, 2017
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic...
K172374 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 8d