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
2065–2088 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 22, 2022
LOGIQ P10, LOGIQ P9, LOGIQ P8
K214039 · IYN
GE Medical Systems Ultrasound and...
Radiology · 89d
Cleared Mar 22, 2022
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
K212960 · IYN
Canon Medical Systems Corporation
Radiology · 187d
Cleared Mar 21, 2022
BriefCase
K213721 · QAS
Aidoc Medical , Ltd.
Radiology · 117d
Cleared Mar 18, 2022
SURGIVISIO Device
K220627 · OWB
Ecential Robotics
Radiology · 14d
Cleared Mar 16, 2022
Customize
K213779 · QIH
3D-Side S.A.
Radiology · 103d
Cleared Mar 16, 2022
EchoSK and EchoSGyn modules for EchoS Family devices
K212851 · IYO
Echolight S.P.A
Radiology · 190d
Cleared Mar 14, 2022
BriefCase
K214043 · QFM
Aidoc Medical , Ltd.
Radiology · 81d
Cleared Mar 14, 2022
Arterys MICA
K203744 · QIH
Arterys, Inc.
Radiology · 447d
Cleared Mar 11, 2022
MAGNETOM Vida, MAGNETOM Sola
K220425 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 25d
Cleared Mar 11, 2022
Dental sensors NanoPix1, NanoPix2
K220422 · MUH
Iray Technology Taicang , Ltd.
Radiology · 25d
Cleared Mar 11, 2022
CardIQ Suite
K213725 · JAK
GE Medical Systems SCS
Radiology · 105d
Cleared Mar 11, 2022
32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR...
K213687 · MOS
Neocoil, LLC
Radiology · 108d
Cleared Mar 11, 2022
RI.HIP MODELER
K212040 · LLZ
Blue Belt Technologies, Inc.
Radiology · 254d
Cleared Mar 10, 2022
ClearRead Xray Pneumothorax
K213566 · QFM
Riverain Technologies, Inc.
Radiology · 121d
Cleared Mar 10, 2022
Smile-100 System
K212965 · LHQ
Niramai Health Analytix Private Limited
Radiology · 175d
Cleared Mar 09, 2022
ZEN-2090 Turbo
K211780 · OWB
Genoray Co., Ltd.
Radiology · 273d
Cleared Mar 07, 2022
syngo.CT Applications
K220450 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 18d
Cleared Mar 04, 2022
TE Air Diagnostic Ultrasound System
K220051 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 57d
Cleared Mar 04, 2022
Skanmobile, Skanmobile-Dr
K212940 · IZL
Skanray Technologies Limited
Radiology · 170d
Cleared Mar 04, 2022
Second Opinion
K210365 · MYN
Pearl, Inc.
Radiology · 389d
Cleared Mar 03, 2022
MR Elastography
K220018 · LNH
Canon Medical Systems Corporation
Radiology · 57d
Cleared Mar 03, 2022
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed...
K213516 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 120d
Cleared Mar 03, 2022
nordicDSC
K212720 · LLZ
Nordicneurolab AS
Radiology · 188d
Cleared Mar 03, 2022
OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with...
K211658 · MOS
Noras Mri Products GmbH
Radiology · 279d