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
1153–1176 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 26, 2024
FCT iSTREAM Phase 1
K233583 · JAK
Fujifilm Healthcare Americas Corporation
Radiology · 171d
Cleared Apr 26, 2024
syngo.via RT Image Suite
K232799 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 227d
Cleared Apr 26, 2024
Pocket III
K232302 · IYO
Quantel Medical
Radiology · 269d
Cleared Apr 26, 2024
DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl
K232298 · OWB
Canon, Inc.
Radiology · 269d
Cleared Apr 25, 2024
Dental Cone-beam Computed Tomography
K240855 · OAS
Yian Medical Technology (Haining)...
Radiology · 28d
Cleared Apr 25, 2024
InVision Precision LVEF (LVEF)
K232331 · QIH
Invision Medical Technology Corporation
Radiology · 265d
Cleared Apr 24, 2024
EPIQ Series Diagnostic Ultrasound Systems
K240850 · IYN
Philips Ultrasound, LLC
Radiology · 28d
Cleared Apr 24, 2024
OpenRad Cloud
K240839 · LLZ
Openrad Services Uk, Ltd.
Radiology · 28d
Cleared Apr 24, 2024
Image Management V15
K240822 · LLZ
Philips Medical Systems Technologies
Radiology · 30d
Cleared Apr 22, 2024
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona...
K240115 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 97d
Cleared Apr 22, 2024
ART-Plan (v.2.2.0)
K234068 · MUJ
Therapanacea Sas
Radiology · 122d
Cleared Apr 22, 2024
Rapid
K233582 · LLZ
Ischemaview, Inc.
Radiology · 172d
Cleared Apr 18, 2024
RAYSCAN a-Expert
K232325 · MUH
Ray Co., Ltd.
Radiology · 259d
Cleared Apr 17, 2024
uOmnispace.MR
K233186 · QIH
Shanghai United Imaging Healthcare...
Radiology · 202d
Cleared Apr 15, 2024
VisAble.IO
K240773 · QTZ
Techsomed
Radiology · 25d
Cleared Apr 12, 2024
OASIS MRI System
K240571 · LNH
Fujifilm Healthcare Corporation
Radiology · 43d
Cleared Apr 12, 2024
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction...
K240238 · LNH
Canon Medical Systems Corporation
Radiology · 74d
Cleared Apr 12, 2024
VenusX
K232489 · IYE
Linatech, LLC
Radiology · 239d
Cleared Apr 11, 2024
True Enhance DL
K233698 · JAK
Ge Healthcare Japan Corporation
Radiology · 146d
Cleared Apr 10, 2024
uMR 680
K240744 · LNH
Shanghai United Imaging Healthcare...
Radiology · 23d
Cleared Apr 10, 2024
Neorad Pacs (Neorad Pacs)
K232641 · LLZ
Everrtech Software Pvt, Ltd.
Radiology · 224d
Cleared Apr 09, 2024
Universal Endometrial Applicator Set (GM11009840)
K232623 · JAQ
Varian Medical Systems, Inc.
Radiology · 224d
Cleared Apr 09, 2024
CAAS Workstation
K232147 · QHA
Pie Medical Imaging BV
Radiology · 265d
Not Cleared Apr 09, 2024
Rho
DEN230023 · SAO
16 Bit, Inc.
Radiology · 372d