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
721–744 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 23, 2025
Annalise Enterprise
K250831 · QFM
Annalise-Ai
Radiology · 35d
Cleared Apr 23, 2025
eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E,...
K250228 · IYN
Esonic Technology (Wuhan) Co., Ltd.
Radiology · 86d
Cleared Apr 23, 2025
MySpine WebPlanner
K243697 · LLZ
Medacta International S.A.
Radiology · 145d
Cleared Apr 21, 2025
VersaViewer
K243651 · LLZ
GE Medical Systems SCS
Radiology · 146d
Cleared Apr 18, 2025
Wireless/ Wired X-Ray Flat Panel Detectors
K243734 · MQB
Allengers Medical Systems Limited
Radiology · 135d
Cleared Apr 18, 2025
ULTRA 1040
K241996 · IZL
Ecoray Co., Ltd.
Radiology · 283d
Cleared Apr 17, 2025
Dental Cone Beam Computed Tomography System
K243337 · OAS
Yofo Medical Technology Co., Ltd.
Radiology · 174d
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