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
2833–2856 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 05, 2020
CURA 778
K192590 · JAK
Fmi Medical Systems, Inc.
Radiology · 167d
Cleared Mar 05, 2020
Kinepict Medical Imaging Tool version v2.2
K190993 · LLZ
Kinepict Health, Ltd.
Radiology · 324d
Cleared Mar 04, 2020
Broncholab
K191550 · JAK
Fluidda, Inc.
Radiology · 266d
Cleared Mar 02, 2020
Vantage Galan 3T, MRT-3020, V6.0
K192506 · LNH
Canon Medical Systems Corporation
Radiology · 172d
Cleared Feb 28, 2020
R-Sensor, R-Sensor
K200284 · MUH
Remedi Co., Ltd.
Radiology · 23d
Cleared Feb 28, 2020
CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid...
K200221 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 30d
Cleared Feb 28, 2020
Alta Multipurpose Device
K193243 · IYE
Qfix
Radiology · 95d
Cleared Feb 28, 2020
icobrain-ctp
K192962 · LLZ
Icometrix NV
Radiology · 129d
Cleared Feb 28, 2020
Magnetom Sola, Magnetom Altea and Magnetom Sola Fit
K192496 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 170d
Cleared Feb 28, 2020
AccuContour
K191928 · QKB
Xiamen Manteia Technology , Ltd.
Radiology · 224d
Cleared Feb 28, 2020
Red Dot
K191556 · QFM
Behold.Ai Technologies Limited
Radiology · 261d
Cleared Feb 25, 2020
Ez3D-i /E3
K200178 · LLZ
Ewoosoft Co., Ltd.
Radiology · 32d
Cleared Feb 25, 2020
uCT 530, uCT 550
K200016 · JAK
Shanghai United Imaging Healthcare...
Radiology · 53d
Cleared Feb 25, 2020
SonicEye Dual-Array Ultrasound System
K192253 · IYO
Sonivate Medical, Inc.
Radiology · 189d
Cleared Feb 21, 2020
3MP Monochrome Digital Mammography LCD Monitor MS-S300
K200161 · PGY
Jvckenwood Corporation
Radiology · 30d
Cleared Feb 21, 2020
OASIS MRI System
K192851 · LNH
Hitachi Healthcare Americas
Radiology · 141d
Cleared Feb 21, 2020
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
K192832 · JAK
Canon Medical Systems Corporation
Radiology · 142d
Cleared Feb 21, 2020
Beamscan MR
K191646 · IYE
Ptw-Freiburg...
Radiology · 246d
Cleared Feb 20, 2020
X-MIND Trium
K191719 · MUH
De Gotzen S.R.L.
Radiology · 239d
Cleared Feb 19, 2020
densitas densityai
K192973 · LLZ
Densitas, Inc.
Radiology · 118d
Cleared Feb 18, 2020
Collaboration Live
K200179 · LLZ
Philips Health Care
Radiology · 25d
Cleared Feb 18, 2020
Ashvins
K200132 · LLZ
Medicalcommunications GmbH
Radiology · 28d
Cleared Feb 18, 2020
Vita Flex CR System with LLI
K192894 · MQB
Carestream Health, Inc.
Radiology · 130d
Cleared Feb 14, 2020
E-COM DR-2000 DR
K193644 · MQB
Livermoretech, Inc.
Radiology · 46d