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
529–552 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Sep 05, 2025
ViewMate™ Multi Ultrasound System (VMM-ICE-01)
K251250 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 135d
Cleared Sep 05, 2025
3D-SHAPER
K251022 · KGI
3D-Shaper Medical S.L
Radiology · 156d
Cleared Sep 04, 2025
Careverse CoronaryDoc (Careverse CoronaryDoc)
K251656 · QIH
Careverse Technology Pte. , Ltd.
Radiology · 97d
Cleared Sep 04, 2025
Rapid Obstructive Hydrocephalus, Rapid OH
K251533 · QAS
Ischemaview, Inc.
Radiology · 108d
Cleared Sep 04, 2025
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
K251438 · EHD
Guilin Woodpecker Medical Instrument...
Radiology · 118d
Cleared Sep 04, 2025
Image Suite
K251168 · LLZ
Carestream Health, Inc.
Radiology · 142d
Cleared Sep 04, 2025
Dose+ (1.0)
K250064 · MUJ
Mvision AI OY
Radiology · 237d
Cleared Sep 03, 2025
Tempus Pixel
K252539 · QIH
Arterys, Inc.
Radiology · 22d
Cleared Sep 03, 2025
AquaCast Mask
K252174 · IYE
Blessing Cathay Corporation
Radiology · 54d
Cleared Sep 02, 2025
OsteoSight™ Hip (v1)
K251408 · SAO
Naitive Technologies, Ltd.
Radiology · 119d
Cleared Sep 02, 2025
VELMENI for DENTISTS (V4D)
K250753 · MYN
Velmeni, Inc.
Radiology · 174d
Cleared Aug 29, 2025
Sonosite LX and Sonosite PX Ultrasound Systems
K251106 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 140d
Cleared Aug 29, 2025
SurgiTwin
K250290 · LLZ
Twinsight
Radiology · 210d
Cleared Aug 29, 2025
PRAEVAorta®2
K243859 · QIH
Nurea
Radiology · 256d