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
313–336 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 16, 2025
IDENTIFY (5.0)
K252919 · IYE
Varian Medical Systems, Inc.
Radiology · 95d
Cleared Dec 16, 2025
SKAN C PULSAR
K251893 · OWB
Skanray Technologies Limited
Radiology · 179d
Cleared Dec 16, 2025
IRISeg
K251763 · QIH
Intuitive Surgical, Inc.
Radiology · 190d
Cleared Dec 12, 2025
Swoop® Portable MR Imaging® System
K253489 · LNH
Hyperfine, Inc.
Radiology · 49d
Cleared Dec 11, 2025
CogNet AI-MT+
K252482 · QFM
Medcognetics, Inc.
Radiology · 126d
Cleared Dec 11, 2025
MIM – LesionID Pro
K251883 · LLZ
Mim Software, Inc.
Radiology · 174d
Cleared Dec 09, 2025
Allia Moveo
K251199 · OWB
GE Medical Systems SCS
Radiology · 235d
Cleared Dec 08, 2025
Fetal EchoScan (v1.2)
K252294 · POK
Brightheart
Radiology · 138d
Cleared Dec 05, 2025
Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11...
K252498 · IYN
Sonoscape Medical Corp.
Radiology · 119d
Cleared Dec 05, 2025
OncoPatch
K252296 · KXK
Oncopatch, Inc.
Radiology · 135d
Cleared Dec 05, 2025
Overjet CBCT Assist
K251514 · QIH
Overjet, Inc.
Radiology · 203d
Cleared Dec 05, 2025
ARTAssistant
K250780 · QKB
Manteia Technologies Co., Ltd.
Radiology · 266d
Cleared Dec 04, 2025
ASUS Ultrasound Imaging System (LU800 series)
K250791 · IYN
Asustek Computer, Inc.
Radiology · 265d
Cleared Dec 03, 2025
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus...
K251601 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 190d
Cleared Dec 03, 2025
AVIEW Lung Nodule CAD
K251203 · OEB
Coreline Soft Co., Ltd.
Radiology · 229d
Cleared Dec 03, 2025
GentleBeam (GB1000)
K250692 · JAD
Voxel Ray Solutions, LLC
Radiology · 271d
Cleared Dec 02, 2025
Acorn 3D Software (AC-SEG-4009)
K252103 · QIH
Mighty Oak Medical
Radiology · 152d
Cleared Dec 01, 2025
Cartesion Prime (PCD-1000A/3) V10.21
K251370 · KPS
Canon Medical Systems Corporation
Radiology · 213d
Cleared Nov 28, 2025
CT VScore+
K252217 · JAK
Canon Medical Informatics, Inc.
Radiology · 136d
Cleared Nov 26, 2025
OEC One CFD
K253269 · OXO
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 58d
Cleared Nov 26, 2025
uDR Arria & uDR Aris
K252000 · KPR
Shanghai United Imaging Healthcare...
Radiology · 152d
Cleared Nov 25, 2025
7600 Ultrasound System (MyLabC25)
K253310 · IYN
Esaote, S.P.A.
Radiology · 57d
Cleared Nov 25, 2025
RCT700
K251798 · OAS
Ray Co., Ltd.
Radiology · 166d
Cleared Nov 25, 2025
PennPET Explorer Positron Emission Tomograph
K251401 · KPS
Trustees of the University of...
Radiology · 203d