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 ×
15,695 results
1273–1296 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 08, 2024
LungQ v3.0.0
K232412 · JAK
Thirona BV
Radiology · 151d
Cleared Jan 08, 2024
DASI Dimensions (V1.0)
K231324 · QIH
Dasi Simulations
Radiology · 245d
Cleared Jan 05, 2024
VEA Align
K231917 · QIH
Eos Imaging
Radiology · 190d
Cleared Jan 05, 2024
ArcherQA (V1.0)
K231273 · IYE
Wisdom Technologies., Inc.
Radiology · 248d
Cleared Jan 04, 2024
Butterfly iQ3 Ultrasound System
K232808 · IYN
Butterfly Network, Inc.
Radiology · 114d
Cleared Jan 04, 2024
syngo.CT Applications
K232136 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 170d
Cleared Jan 03, 2024
Portable Dental X-Ray (AXR60 S)
K233395 · EHD
Alliage S/A Industrias M?dico...
Radiology · 92d
Cleared Jan 03, 2024
Horos MD™
K232589 · LLZ
Icat Solutions, Ltd.
Radiology · 131d
Cleared Dec 29, 2023
Bladder Scanner
K230986 · IYO
Avantsonic Technology Co., Ltd.
Radiology · 267d
Cleared Dec 28, 2023
x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark...
K231055 · EHD
De G?tzen S.R.L.
Radiology · 259d
Cleared Dec 28, 2023
Planmeca Viso
K230985 · OAS
Planmeca Oy
Radiology · 266d
Cleared Dec 26, 2023
TumorSight Viz
K231130 · QIH
SimBioSys, Inc.
Radiology · 250d
Cleared Dec 22, 2023
Interson USB Ultrasound System
K233734 · IYN
Interson Corporation
Radiology · 30d
Cleared Dec 22, 2023
TP Pivot Pro™ Needle Guide
K233109 · ITX
Civco Medical Solutions
Radiology · 86d
Cleared Dec 22, 2023
MAGNETOM Sola
K232535 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 123d
Cleared Dec 22, 2023
ART-Plan
K232479 · MUJ
Therapanacea
Radiology · 128d
Cleared Dec 22, 2023
kallisio stentra™ oral stent
K232293 · IYE
Kallisio, Inc.
Radiology · 143d
Cleared Dec 22, 2023
qXR-LN
K231805 · MYN
Qure.Ai Technologies
Radiology · 185d
Not Cleared Dec 22, 2023
BioTraceIO Lite
DEN230020 · QZL
Techsomed Medical Technologies , Ltd.
Radiology · 267d
Cleared Dec 21, 2023
RadiForce MX317W
K233465 · PGY
Eizo Corporation
Radiology · 58d
Cleared Dec 21, 2023
HM70 EVO Diagnostic Ultrasound System
K233112 · IYN
Samsung Medison Co., Ltd.
Radiology · 85d
Cleared Dec 21, 2023
TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)
K232870 · IYE
Varian Medical Systems, Inc.
Radiology · 97d
Cleared Dec 21, 2023
syngo Virtual Cockpit (VB10A)
K232744 · LLZ
Siemens Healthcare GmbH
Radiology · 105d
Cleared Dec 21, 2023
iSR`obot Mona Lisa 2.0
K232320 · IYO
Biobot Surgical Pte., Ltd.
Radiology · 140d