FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
1969–1992 of 15,589
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