Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Radiology × Cleared only ×
15,676 results
2497–2520 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 26, 2021
SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System
K201967 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 226d
Cleared Feb 26, 2021
Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)
K201316 · IYO
Suzhou Peaksonic Medical Technology...
Radiology · 284d
Cleared Feb 25, 2021
NinesMeasure
K202990 · LLZ
Nines, Inc.
Radiology · 148d
Cleared Feb 25, 2021
EchoS Family
K202514 · MUA
Echolight S.P.A
Radiology · 178d
Cleared Feb 25, 2021
SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System
K201971 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 225d
Cleared Feb 25, 2021
SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System
K201969 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 225d
Cleared Feb 23, 2021
PreXion3D Explorer PRO
K203784 · OAS
Prexion Corporation
Radiology · 57d
Cleared Feb 23, 2021
Lumify Diagnostic Ultrasound System
K203406 · IYN
Philips Ultrasound, Inc.
Radiology · 96d
Cleared Feb 23, 2021
Monaco Rtp System
K202789 · MUJ
Elekta Solutions AB
Radiology · 154d
Cleared Feb 23, 2021
ClarifEye R1.0, ClarifEye Needle
K201743 · OWB
Philips Medical Systems Nederlands B.V.
Radiology · 243d
Cleared Feb 23, 2021
Veolity
K201501 · OEB
Mevis Medical Solutions AG
Radiology · 263d
Cleared Feb 19, 2021
X-ray Flat Panel Detectors/CareView 3600RF
K202995 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 141d
Cleared Feb 19, 2021
TruPlan
K202212 · LLZ
Circle Cardiovascular Imaging, Inc.
Radiology · 197d
Cleared Feb 19, 2021
Disposable Intraoperative Probe (DIOP8)
K201425 · ITX
Huntleigh Healthcare Limited
Radiology · 266d
Cleared Feb 19, 2021
MyPAO Planning Report
K200589 · LLZ
Medacta International S.A.
Radiology · 350d
Cleared Feb 18, 2021
Green X 18(Model : PHT-75CHS)
K210329 · OAS
VATECH Co., Ltd.
Radiology · 14d
Cleared Feb 18, 2021
PhantomMSK Hip
K210136 · LLZ
OrthoGrid Systems, Inc.
Radiology · 30d
Cleared Feb 18, 2021
3D Accuitomo 150N
K201378 · OAS
J. Morita USA, Inc.
Radiology · 268d
Cleared Feb 16, 2021
Vitrea Software Package, VSTP-001A
K203312 · LLZ
Canon Medical Systems Corporation
Radiology · 98d
Cleared Feb 16, 2021
VesselIQ Xpress
K200626 · JAK
GE Medical Systems SCS
Radiology · 343d
Cleared Feb 12, 2021
4D Integrated Treatment Console
K203766 · MUJ
Varian Medical Systems, Inc.
Radiology · 51d
Cleared Feb 09, 2021
Synapse 3D, Synapse 3D Base Tools v6.1
K203103 · LLZ
Fujifilm Corporation
Radiology · 118d
Cleared Feb 09, 2021
SmartCT R1.0
K201583 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 243d
Cleared Feb 05, 2021
Cios Alpha
K210055 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 28d