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
2929–2952 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 11, 2019
NemoScan
K192571 · LLZ
Software Nemotec S.L.
Radiology · 84d
Cleared Dec 10, 2019
HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System
K192319 · IYN
Samsung Medison Co., Ltd.
Radiology · 106d
Cleared Dec 10, 2019
Transpara
K192287 · QDQ
Screenpoint Medical B.V.
Radiology · 110d
Cleared Dec 07, 2019
PhantomMSK Trauma
K192279 · LLZ
OrthoGrid Systems, Inc.
Radiology · 107d
Cleared Dec 05, 2019
Digital Intraoral Imaging Plate System
K192766 · MUH
Fsusen Technology Co., Ltd.
Radiology · 66d
Cleared Dec 05, 2019
Elekta Unity
K192482 · IYE
Elekta Limited
Radiology · 86d
Cleared Dec 05, 2019
21HK512D
K191864 · PGY
Lg Electronics.Inc
Radiology · 146d
Cleared Dec 04, 2019
SICAT Implant V2.0
K192348 · LLZ
Sicat GmbH & Co. KG
Radiology · 97d
Cleared Dec 02, 2019
Emprint Visualization Application
K192038 · LLZ
Covidien, LLC
Radiology · 125d
Cleared Nov 27, 2019
Diagnostic Ultrasound System
K192791 · IYO
Edan Instruments, Inc.
Radiology · 58d
Cleared Nov 27, 2019
EOSedge
K192079 · KPR
Eos Imaging
Radiology · 117d
Cleared Nov 27, 2019
fMRI Hardware System
K191032 · LNH
Nordicneurolab AS
Radiology · 223d
Cleared Nov 26, 2019
HealthCXR
K192320 · QFM
Zebra Medical Vision, Ltd.
Radiology · 92d
Cleared Nov 22, 2019
EXPD 4343P, EXPD 3643P
K193031 · MQB
DRTECH Corporation
Radiology · 23d
Cleared Nov 22, 2019
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
K193017 · MQB
DRTECH Corporation
Radiology · 24d
Cleared Nov 22, 2019
Medsynapse Ris Pacs & Medsynapse VNA
K192508 · LLZ
Medsynaptic Private, Ltd.
Radiology · 71d
Cleared Nov 22, 2019
Synergy Platform, Synergy, Infinity, VersaHD
K192242 · IYE
Elekta Limited
Radiology · 95d
Cleared Nov 22, 2019
6450 Ultrasound system
K192157 · IYN
Esaote, S.P.A.
Radiology · 105d
Cleared Nov 21, 2019
SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open...
K192061 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 112d
Cleared Nov 20, 2019
uPMR 790
K192672 · OUO
Shanghai United Imaging Healthcare...
Radiology · 55d
Cleared Nov 20, 2019
Ziehm 8000
K190497 · OWB
Ziehm Imaging GmbH
Radiology · 265d
Cleared Nov 19, 2019
Dolphin Medical Imaging USB Ultrasound System
K192573 · IYO
Dolphin Medical Imaging, LLC
Radiology · 62d
Cleared Nov 19, 2019
RSI-MRI+
K191278 · LLZ
Multimodal Imaging Services...
Radiology · 190d
Cleared Nov 15, 2019
Soltus 500
K192936 · IZL
Sedecal., Sa.
Radiology · 28d