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 × Cleared only ×
15,570 results
409–432 of 15,570
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 23, 2025
Rapid Aortic Measurements
K251987 · QIH
Ischemaview, Inc.
Radiology · 88d
Cleared Sep 23, 2025
SwiftSight-Brain
K251483 · QIH
Airs Medical, Inc.
Radiology · 132d
Cleared Sep 19, 2025
uDR Aurora CX
K251167 · KPR
Shanghai United Imaging Healthcare...
Radiology · 157d
Cleared Sep 19, 2025
Videa Dental AI
K251002 · MYN
Videahealth, Inc.
Radiology · 171d
Cleared Sep 18, 2025
ULTRASONIC PROBE UM-3R (UM-3R)
K250883 · ITX
Olympus Medical Systems Corporation
Radiology · 178d
Cleared Sep 18, 2025
Axial3D Insight
K250369 · QIH
Axial Medical Printing Limited
Radiology · 220d
Cleared Sep 17, 2025
ECHELON Synergy
K251386 · LNH
Fujifilm Corporation
Radiology · 135d
Cleared Sep 16, 2025
Insight Enhanced™ DRF (EN-1002-01)
K251650 · JAA
Imaging Engineering, LLC
Radiology · 110d
Cleared Sep 15, 2025
InferOperate Suite
K250237 · QIH
Beijing Infervision Healthcare...
Radiology · 231d
Cleared Sep 12, 2025
ViewMateTM Ultrasound System
K251820 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 91d
Cleared Sep 12, 2025
FETOLY
K251368 · IYN
Diagnoly
Radiology · 134d
Cleared Sep 12, 2025
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
K250986 · LHN
Mevion Medical Systems, Inc.
Radiology · 165d
Cleared Sep 12, 2025
uWS-Angio
K250040 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 247d
Cleared Sep 12, 2025
BONX805
K243864 · IZL
Bontech Co., Ltd.
Radiology · 269d
Cleared Sep 11, 2025
SIGNA™ Sprint
K251399 · LNH
Ge Medical Systems, LLC
Radiology · 128d
Cleared Sep 11, 2025
Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)
K242314 · LLZ
Augment Intelligent Medical System...
Radiology · 402d
Cleared Sep 10, 2025
AngioWaveNet
K244002 · QIH
Angiowave Imaging, Inc.
Radiology · 258d
Cleared Sep 09, 2025
AI-Rad Companion Prostate MR
K252608 · LLZ
Siemens Healthcare GmbH
Radiology · 22d
Cleared Sep 09, 2025
Hybrid Viewer (00859873006240)
K252477 · KPS
Hermes Medical Solutions AB
Radiology · 33d
Cleared Sep 09, 2025
MuscleView 2.0
K251682 · LNH
Springbok, Inc. (Dba Springbok...
Radiology · 102d
Cleared Sep 09, 2025
Segmentron Viewer
K251072 · QIH
DGNCT, LLC
Radiology · 155d
Cleared Sep 08, 2025
BioTraceIO Vision (V1.7)
K251931 · QTZ
Techsomed Medical Technologies
Radiology · 76d
Cleared Sep 08, 2025
qER-CTA (v1.0)
K251610 · QAS
Qure.Ai Technologies
Radiology · 104d
Cleared Sep 08, 2025
OmniTom Elite with PCD
K250928 · JAK
Neurologica Corporation
Radiology · 164d