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
2785–2808 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 09, 2020
EchoNavigator
K200713 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 22d
Cleared Apr 09, 2020
hyperion X5, NewTom GO, X-RADiUS COMPACT
K200688 · OAS
Cefla S.C.
Radiology · 24d
Cleared Apr 09, 2020
MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus...
K200001 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 98d
Cleared Apr 09, 2020
ClearCalc
K193640 · MUJ
Radformation, Inc.
Radiology · 104d
Cleared Apr 09, 2020
PreXion3D Explorer EX
K193329 · OAS
Prexion Corporation
Radiology · 129d
Cleared Apr 08, 2020
Flex Body Speeder
K200477 · MOS
Quality Electrodynamics, LLC
Radiology · 41d
Cleared Apr 08, 2020
Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
K200411 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 49d
Cleared Apr 08, 2020
Orfit Aerial Couchtop
K200282 · LHN
Orfit Industries NV
Radiology · 64d
Cleared Apr 08, 2020
AIMI-Triage CXR PTX
K193300 · QFM
Radlogics, Inc.
Radiology · 133d
Cleared Apr 07, 2020
HS40 Diagnostic Ultrasound System
K200339 · IYN
Samsung Medison Co., Ltd.
Radiology · 56d
Cleared Apr 07, 2020
Innovision Audio
K193218 · LNH
Innovere Medical, Inc.
Radiology · 138d
Cleared Apr 03, 2020
Eclipse Treatment Planning System v16.0
K200608 · MUJ
Varian Medical Systems, Inc.
Radiology · 25d
Cleared Apr 03, 2020
FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System
K200022 · OWB
Livermoretech, Inc.
Radiology · 88d
Cleared Apr 02, 2020
Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System
K200251 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 59d
Cleared Apr 02, 2020
IntelePACS
K192176 · LLZ
Intelerad Medical Systems Incorporated
Radiology · 234d
Cleared Apr 01, 2020
Focus 43C detector, TRIMAX 43C detector
K200622 · MQB
Iray Technology Taicang , Ltd.
Radiology · 23d
Cleared Apr 01, 2020
SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All,...
K200524 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Apr 01, 2020
LOGIQ E10s
K200119 · IYN
GE Medical Systems Ultrasound and...
Radiology · 71d
Cleared Mar 31, 2020
Rapid ICH
K193087 · QAS
Ischemaview Incorporated
Radiology · 146d
Cleared Mar 27, 2020
CUBEScan BioCon-1100
K200548 · IYO
Mcube Technology Co., Ltd.
Radiology · 24d
Cleared Mar 27, 2020
uMR Omega
K193200 · LNH
Shanghai United Imaging Healthcare...
Radiology · 128d
Cleared Mar 26, 2020
KOSMOS
K193518 · IYN
EchoNous, Inc.
Radiology · 98d
Cleared Mar 25, 2020
syngo.CT Cardiac Planning
K200515 · JAK
Siemens Medical Soultions USA, Inc.
Radiology · 23d
Cleared Mar 25, 2020
MammoScreen
K192854 · QDQ
Therapixel
Radiology · 173d