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
4297–4320 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 07, 2016
X-VIEW, IMAGEN
K151137 · OAS
Edlen Imaging, LLC
Radiology · 405d
Cleared Jun 02, 2016
16ch Tx/Rx Knee SPEEDER
K161193 · MOS
Quality Electrodynamics, LLC
Radiology · 36d
Cleared Jun 01, 2016
FirstSense Breast Exam
K160573 · LHQ
First Sense Medical, LLC
Radiology · 93d
Cleared Jun 01, 2016
Hermes Medical Imaging Suite v5.6
K153056 · KPS
Hermes Medical Solutions AB
Radiology · 224d
Cleared May 31, 2016
Acclarix AX8 Diagnostic Ultrasound System
K161300 · IYO
Edan Instruments, Inc.
Radiology · 22d
Cleared May 31, 2016
Ez3D-i / E3
K161246 · LLZ
Ewoosoft Co., Ltd.
Radiology · 28d
Cleared May 31, 2016
CT/MR Compatible M.A.C. Interstitial GYN Template
K150979 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 414d
Cleared May 27, 2016
3mensio Workstation
K153736 · LLZ
Pie Medical Imaging BV
Radiology · 151d
Cleared May 25, 2016
Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body...
K153026 · IYE
Medtec, Inc. D/B/A Civco Medical...
Radiology · 222d
Cleared May 20, 2016
ViZion DR + Wireless
K160810 · MQB
Viztek, LLC
Radiology · 57d
Cleared May 20, 2016
Planmeca ProMax 3D Max, Planmeca Maximity
K160506 · OAS
Planmeca Oy
Radiology · 86d
Cleared May 20, 2016
Trillium Oval V 5.1 MRI System
K160152 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 119d
Cleared May 20, 2016
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
K160065 · OXO
Gemss Medical Systems Co., Ltd.
Radiology · 128d
Cleared May 18, 2016
Mammo Tomosynthesis (MDMG-5221)
K161229 · PGY
Barco N.V.
Radiology · 16d
Cleared May 17, 2016
SafeCT-29
K153331 · JAK
Medic Vision Imaging Solutions
Radiology · 180d
Cleared May 13, 2016
SonoSite iViz Ultrasound System
K161119 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 23d
Cleared May 13, 2016
EzDent-i / E2 / Prora View
K161117 · LLZ
Ewoosoft Co., Ltd.
Radiology · 23d
Cleared May 13, 2016
Diagnostic Imaging Color LCD Monitor
K161057 · PGY
Nec Display Solutions , Ltd.
Radiology · 29d
Cleared May 13, 2016
ArcCHECK-MR
K160057 · IYE
Sun Nuclear Corporation
Radiology · 122d
Cleared May 13, 2016
Bindex BI-100
K152020 · MUA
Bone Index Finland , Ltd.
Radiology · 297d
Cleared May 05, 2016
LOGIQ P9 and LOGIQ P7
K161047 · IYN
Ge Healthcare
Radiology · 22d
Cleared May 05, 2016
Enovare Ultrasound System
K153620 · IYO
Oreon Technologies, Inc.
Radiology · 139d
Cleared May 04, 2016
6200 Ultrasound System and 6250 Ultrasound System
K153277 · IYN
Esaote, S.P.A.
Radiology · 174d
Cleared May 02, 2016
TRINITY
K160357 · IYN
Koelis
Radiology · 84d