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
2881–2904 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 26, 2020
Emission Computed Tomography System
K193241 · KPS
Shanghai United Imaging Healthcare...
Radiology · 62d
Cleared Jan 24, 2020
IQon Spectral CT
K193454 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 42d
Cleared Jan 24, 2020
FlightPlan for Embolization
K193261 · LLZ
GE Medical Systems SCS
Radiology · 59d
Cleared Jan 24, 2020
MRCAT brain
K193109 · MUJ
Philips Medical Systems MR Finland
Radiology · 77d
Cleared Jan 23, 2020
VistaScan USB Ultrasound Imaging System
K192170 · IYO
Emagine Solutions Technology, LLC
Radiology · 164d
Cleared Jan 23, 2020
Blue Phantom PT
K191821 · LHN
Iba Dosimetry GmbH
Radiology · 199d
Cleared Jan 23, 2020
Elements Viewer
K191014 · LLZ
Brainlab AG
Radiology · 281d
Cleared Jan 23, 2020
GammaTile
K190839 · KXK
Gt Medical Technologies
Radiology · 297d
Cleared Jan 23, 2020
VINNO 8, VINNO 6, VINNO 5
K190120 · IYN
Vinno Technology (Suzhou) Co.,Ltd
Radiology · 364d
Cleared Jan 22, 2020
Q-Rad System
K193574 · KPR
Carestream Health, Inc.
Radiology · 30d
Cleared Jan 20, 2020
EzMobile
K192098 · LLZ
Ewoosoft Co., Ltd.
Radiology · 168d
Cleared Jan 17, 2020
C015
K192182 · OWB
Micronica Srl
Radiology · 158d
Cleared Jan 16, 2020
Auto Positioning
K192956 · JAK
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 87d
Cleared Jan 15, 2020
KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU...
K193225 · KPR
Konica Minolta Healthcare Americas, Inc.
Radiology · 54d
Cleared Jan 15, 2020
ADAS 3D
K191125 · LLZ
Galgo Medical S.L
Radiology · 261d
Cleared Jan 06, 2020
MRIaudio PREM System with MRIview
K193102 · LNH
Mriaudio, Inc.
Radiology · 59d
Cleared Jan 06, 2020
ViewPoint 6
K192917 · LLZ
Ge Medical Systems Ultrasound And
Radiology · 83d
Cleared Jan 06, 2020
RS85 Diagnostic Ultrasound System
K192903 · IYN
Samsung Medison Co., Ltd.
Radiology · 83d
Cleared Jan 03, 2020
AlignRT Plus
K193431 · IYE
Vision Rt, Ltd.
Radiology · 24d
Cleared Jan 03, 2020
Flex Body SPEEDER
K193140 · MOS
Quality Electrodynamics, LLC
Radiology · 51d
Cleared Jan 02, 2020
Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard
K193360 · KPR
Radmedix, LLC
Radiology · 29d
Cleared Dec 31, 2019
RadCalc Software
K193381 · MUJ
Lifeline Software, Inc.
Radiology · 26d
Cleared Dec 31, 2019
AutoMIStar
K192912 · LLZ
Apollo Medical Imaging Technology...
Radiology · 77d
Cleared Dec 27, 2019
UroNav System
K193403 · LLZ
Invivo Corporation
Radiology · 21d