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
3121–3144 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 14, 2019
JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
K190848 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 43d
Cleared May 13, 2019
SurgicalAR
K190764 · LLZ
Medivis, Inc.
Radiology · 49d
Cleared May 13, 2019
ControlRad Trace Model 8
K183109 · OWB
Controlrad, Inc.
Radiology · 186d
Cleared May 10, 2019
ExactVu High Resolution Micro-Ultrasound System
K190995 · IYN
Exact Imaging, Inc.
Radiology · 24d
Cleared May 10, 2019
6400 Ultrasound System (MyLabX6, MyLabX7)
K190989 · IYN
Esaote, S.P.A.
Radiology · 25d
Cleared May 06, 2019
Biograph Vision
K190900 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared May 06, 2019
HealthPNX
K190362 · QFM
Zebra Medical Vision, Ltd.
Radiology · 80d
Cleared May 06, 2019
MD-6000P Bladder Scanner
K182460 · IYO
MEDA Co., Ltd.
Radiology · 238d
Cleared Apr 30, 2019
TOTIM Patient Cushion Immobilization System
K190894 · IYE
Essebi Medical Srl
Radiology · 25d
Cleared Apr 30, 2019
XmaruView V1 (Xmaru Chiroview, Xmaru Podview)
K190866 · LLZ
Rayence Co., Ltd.
Radiology · 27d
Cleared Apr 30, 2019
MRCAT Pelvis
K182888 · MUJ
Philips Medical Systems MR Finland
Radiology · 197d
Cleared Apr 25, 2019
MasteRad MX30
K190601 · KPR
Medicatech USA
Radiology · 48d
Cleared Apr 25, 2019
Brainlab Elements Image Fusion Angio
K190042 · LLZ
Brainlab AG
Radiology · 106d
Cleared Apr 25, 2019
Synapse Enterprise Viewer Version 1.0
K183248 · LLZ
Fujifilm Corporation
Radiology · 155d
Cleared Apr 24, 2019
RAYSCAN a-Expert3D
K190812 · OAS
Ray Co., Ltd.
Radiology · 26d
Cleared Apr 24, 2019
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
K190496 · OAS
Cefla S.C.
Radiology · 55d
Cleared Apr 19, 2019
Ez3D-i/E3
K190791 · LLZ
Ewoosoft Co., Ltd.
Radiology · 23d
Cleared Apr 18, 2019
Lung Vision System
K183593 · LLZ
Bodyvision Medical , Ltd.
Radiology · 118d
Cleared Apr 16, 2019
“BRAXX” Esophageal Brachytherapy Applicator
K183332 · JAQ
Braxx Biotech Co., Ltd.
Radiology · 134d
Cleared Apr 15, 2019
PreXion3D Explorer
K190320 · OAS
Prexion Corporation
Radiology · 61d
Cleared Apr 15, 2019
BriefCase
K190072 · QAS
Aidoc Medical , Ltd.
Radiology · 90d
Cleared Apr 15, 2019
SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16
K183548 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 116d
Cleared Apr 12, 2019
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive...
K190664 · MUJ
Brainlab AG
Radiology · 28d
Cleared Apr 12, 2019
SyncVision System
K190626 · OWB
Volcano Corporation
Radiology · 32d