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
553–576 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 28, 2025
RadiForce GX570
K252030 · PGY
Eizo Corporation
Radiology · 59d
Cleared Aug 28, 2025
CT:VQ
K251484 · JAK
4Dmedical Limited
Radiology · 106d
Cleared Aug 28, 2025
Definium Tempo Select
K250788 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 167d
Cleared Aug 27, 2025
VistaSoft 4.0 and VisionX 4.0
K250947 · QIH
Durr Dental SE
Radiology · 152d
Cleared Aug 26, 2025
Rapid DeltaFuse
K252526 · LLZ
Ischemaview, Inc.
Radiology · 15d
Cleared Aug 26, 2025
Brainomix 360 Triage Stroke
K251983 · QAS
Brainomix Limited
Radiology · 60d
Cleared Aug 25, 2025
Neurovascular Insight V1.0
K243680 · LLZ
Olea Medical S.A.S.
Radiology · 269d
Cleared Aug 22, 2025
GBrain MRI
K252362 · QIH
Galileo Cds, Inc.
Radiology · 24d
Cleared Aug 22, 2025
PROMO
K251443 · IZL
DRGEM Corporation
Radiology · 105d
Cleared Aug 22, 2025
Diagnostic Ultrasound System (MX7)
K251192 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 127d
Cleared Aug 22, 2025
MammoScreen BD
K243685 · QIH
Therapixel
Radiology · 266d
Cleared Aug 21, 2025
Vista OS, Vista AI Scan, RTHawk
K251029 · LNH
Vista AI, Inc.
Radiology · 141d
Cleared Aug 20, 2025
Salix Coronary Plaque (V1.0.0)
K251837 · QIH
Artrya Limited
Radiology · 65d
Cleared Aug 20, 2025
Methinks CTA Stroke
K251590 · QAS
Methinks Software, S.L
Radiology · 89d
Cleared Aug 20, 2025
ACUSON Sequoia Diagnostic Ultrasound System
K251481 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 99d
Cleared Aug 15, 2025
VEA Align
K251747 · QIH
Eos Imaging
Radiology · 70d
Cleared Aug 15, 2025
PHAROS
K250170 · KPS
Brightonix Imaging
Radiology · 206d
Cleared Aug 12, 2025
DS Core Diagnosis
K250755 · QIH
Dentsply Sirona, Inc.
Radiology · 153d
Cleared Aug 11, 2025
Saige-Dx
K251873 · QDQ
DeepHealth, Inc.
Radiology · 54d
Cleared Aug 11, 2025
RW-1
K232456 · LLZ
Mediott, Inc.
Radiology · 728d
Cleared Aug 07, 2025
UNiD™ Spine Analyzer
K251629 · QIH
Medicrea International S.A.S....
Radiology · 71d
Cleared Aug 07, 2025
Navigo Workstation 2.3 (FPRMC00039)
K250664 · LLZ
UC-CARE , Ltd.
Radiology · 155d
Cleared Aug 06, 2025
InVision™ 3T Recharge Operating Suite
K252239 · LNH
Imris Imaging, Inc.
Radiology · 20d
Cleared Aug 06, 2025
Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
K251038 · LLZ
Shen Zhen Cambridge-Hit Co., Ltd.
Radiology · 125d