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
625–648 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 17, 2025
RayCare (2024A SP1)
K242992 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 203d
Cleared Apr 16, 2025
Nanox.ARC X
K250850 · IZF
Nano-X Imaging , Ltd.
Radiology · 27d
Cleared Apr 16, 2025
Clarius Prostate AI
K243853 · QIH
Clarius Mobile Health Corp.
Radiology · 121d
Cleared Apr 16, 2025
MySegmenter (v2.0.0)
K242647 · LLZ
Mysegmenter Technologies, Inc.
Radiology · 225d
Cleared Apr 16, 2025
LARALAB
K242500 · QIH
Laralab GmbH
Radiology · 237d
Cleared Apr 15, 2025
SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
K250650 · JAK
Arineta , Ltd.
Radiology · 42d
Cleared Apr 14, 2025
Merge Universal Viewer (MUV)
K250301 · LLZ
Merge Healthcare Incorporated
Radiology · 73d
Cleared Apr 11, 2025
GBrain MRI
K250416 · QIH
Galileo Cds, Inc.
Radiology · 57d
Cleared Apr 11, 2025
Oncospace
K242748 · MUJ
Oncospace, Inc.
Radiology · 211d
Cleared Apr 11, 2025
Second Opinion Periapical Radiolucency Contours
K242600 · MYN
Pearl, Inc.
Radiology · 224d
Cleared Apr 10, 2025
cmAngio® (V1.6)
K250754 · QIH
Curemetrix, Inc.
Radiology · 29d
Cleared Apr 10, 2025
EPIQ Series Diagnostic Ultrasound System
K250177 · IYN
Philips Ultrasound, LLC
Radiology · 78d
Cleared Apr 10, 2025
Vitrea CT VScore
K243240 · JAK
Canon Medical Informatics, Inc.
Radiology · 182d
Cleared Apr 10, 2025
syngo.CT LVO Detection
K243145 · QAS
Siemens Medical Solutions USA, Inc.
Radiology · 192d
Cleared Apr 08, 2025
Horos Mobile
K242552 · LLZ
Icat Solutions, Ltd.
Radiology · 224d
Cleared Apr 08, 2025
BunkerHill BMD
K242295 · KGI
BunkerHill Health
Radiology · 249d
Cleared Apr 04, 2025
QFR (3.0)
K243769 · QHA
Qfr Solutions BV
Radiology · 119d
Cleared Apr 04, 2025
HeartFocus (V.1.1.1)
K242807 · QJU
Deski
Radiology · 199d
Cleared Apr 04, 2025
DeepFoqus (DeepFoqus-Accelerate)
K241982 · QIH
Foqus Technologies, Inc.
Radiology · 273d
Cleared Apr 04, 2025
RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation...
K240398 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 420d
Cleared Apr 03, 2025
Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic...
K243298 · IYN
Carbon (Shenzhen) Medical Device Co.,...
Radiology · 167d
Cleared Apr 03, 2025
syngo Dynamics (Version VA41D)
K242551 · QIH
Siemens Healthcare GmbH
Radiology · 219d
Cleared Apr 02, 2025
Hi-D Imaging 4TAVR
K241984 · QIH
Hi-D Imaging AG
Radiology · 268d
Cleared Apr 01, 2025
MR Contour DL
K242925 · QKB
Ge Healthcare
Radiology · 189d