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
3289–3312 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 30, 2018
SubtlePET
K182336 · KPS
Subtle Medical, Inc.
Radiology · 94d
Cleared Nov 30, 2018
FerriSmart Analysis System
K182218 · PCS
Resonance Health Analysis Services...
Radiology · 107d
Cleared Nov 30, 2018
Planmed Verity
K180918 · OAS
Planmed OY
Radiology · 235d
Cleared Nov 26, 2018
Corin Optimized Positioning System (OPS) Plan
K183038 · LLZ
Corin USA
Radiology · 25d
Cleared Nov 26, 2018
Vitrea Software Package, VSTP-001A
K183013 · LLZ
Canon Medical Systems Corporation
Radiology · 26d
Cleared Nov 26, 2018
Konicaminolta DI-X1
K182431 · LLZ
Konica Minolta, Inc.
Radiology · 81d
Cleared Nov 26, 2018
ARiX RAD Radiographic System
K182134 · KPR
Compania Mexicana DE Radiologia Cgr,...
Radiology · 112d
Cleared Nov 23, 2018
Motion Tracking and Compensation Feature for the Radixact Treatment Delivery...
K182687 · IYE
Accuray Incorporated
Radiology · 58d
Cleared Nov 21, 2018
Versana Premier
K182277 · IYN
GE Medical Systems Ultrasound and...
Radiology · 91d
Cleared Nov 21, 2018
Transpara
K181704 · QDQ
Screenpoint Medical B.V.
Radiology · 147d
Cleared Nov 21, 2018
DENTIOIII series (DENTIOIII, DENTIOIII-S)
K181297 · MUH
Hdx Will Corp.
Radiology · 189d
Cleared Nov 21, 2018
ProFuse CAD
K173744 · LLZ
Eigen
Radiology · 349d
Cleared Nov 20, 2018
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System
K182715 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 54d
Cleared Nov 20, 2018
6MP Color LCD Monitor (C61W+)
K182291 · PGY
Shenzhen Beacon Display Technology...
Radiology · 89d
Cleared Nov 20, 2018
Vitrea CT Brain Perfusion
K181247 · LLZ
Vital Images, Inc.
Radiology · 194d
Cleared Nov 16, 2018
1.5T 16ch Breast Coil
K182958 · MOS
Neocoil, LLC
Radiology · 23d
Cleared Nov 16, 2018
OEC One
K182626 · OXO
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 53d
Cleared Nov 16, 2018
1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
K181948 · MOS
Rapid Biomedical GmbH
Radiology · 119d
Cleared Nov 16, 2018
Celesteion, PCA-9000A/3, V6.5
K181646 · JAK
Canon Medical Systems Corporation
Radiology · 147d
Cleared Nov 15, 2018
Voluson E6, Voluson E8, Voluson E10
K181985 · IYN
Ge Healthcare
Radiology · 113d
Cleared Nov 14, 2018
Z6 Diagnostic Ultrasound System
K182603 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 54d
Cleared Nov 13, 2018
RectalPro 75 Endorectal Balloon
K180478 · PCT
Qlrad International , Ltd.
Radiology · 264d
Cleared Nov 09, 2018
EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ...
K182857 · IYN
Philips Ultrasound, Inc.
Radiology · 30d
Cleared Nov 09, 2018
VERITON CT whole body SPECT/CT system
K182484 · KPS
Spectrum Dynamics Medical, Ltd.
Radiology · 59d