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
673–696 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 14, 2025
PLANET Onco Dose (3.2)
K241765 · LLZ
Dosisoft SA
Radiology · 267d
Cleared Mar 13, 2025
Ziehm Vision FD
K243735 · OWB
Ziehm Imaging GmbH
Radiology · 99d
Cleared Mar 12, 2025
RCT600
K243903 · OAS
Ray Co., Ltd.
Radiology · 83d
Cleared Mar 12, 2025
2430TCA with Xmaru W
K243849 · MUE
Rayence Co., Ltd.
Radiology · 86d
Cleared Mar 11, 2025
Better Diagnostics Caries Assist (BDCA) Version 1.0
K241725 · MYN
Better Diagnostics AI Corp.
Radiology · 270d
Cleared Mar 07, 2025
Cleerly LABS (v2.0)
K242338 · QIH
Cleerly, Inc.
Radiology · 212d
Cleared Mar 06, 2025
LVivo Seamless
K243331 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 133d
Cleared Mar 05, 2025
Prostate MR AI (VA10A)
K241770 · QDQ
Siemens Healthcare GmbH
Radiology · 258d
Cleared Mar 04, 2025
Ceevra Reveal 3+
K243933 · QIH
Ceevra, Inc.
Radiology · 74d
Cleared Mar 03, 2025
Titanium Flexible Geometry FSD Applicator Set (GM11013400)
K243939 · JAQ
Varian Medical Systems, Inc.
Radiology · 73d
Cleared Mar 03, 2025
HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and...
K243881 · KPS
Bracco Diagnostics, Inc.
Radiology · 75d
Cleared Mar 03, 2025
JLK-SDH
K243611 · QAS
JLK, Inc.
Radiology · 101d
Cleared Mar 03, 2025
LVivo Software Application
K243235 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 144d
Cleared Feb 28, 2025
16ch Flex SPEEDER Medium 1.5T (Q7000246)
K244054 · MOS
Quality Electrodynamics
Radiology · 59d
Cleared Feb 28, 2025
Myomics
K241922 · QIH
Phantomics, Inc.
Radiology · 242d
Cleared Feb 27, 2025
ChestView US
K241620 · MYN
Gleamer Sas
Radiology · 267d
Cleared Feb 26, 2025
aiCockpit AI Viewer
K241546 · LLZ
Fovia, Inc.
Radiology · 271d
Cleared Feb 26, 2025
Ventripoint Medical System Plus (VMS+) 4.0
K241222 · QIH
Ventripoint Diagnostics , Ltd.
Radiology · 301d
Cleared Feb 25, 2025
JLK-AILink
K250348 · LLZ
JLK, Inc.
Radiology · 19d
Cleared Feb 25, 2025
3DXR
K243446 · OWB
GE Medical Systems SCS
Radiology · 111d
Cleared Feb 25, 2025
ART-Plan+ (v.3.0.0)
K242822 · MUJ
Therapanacea Sas
Radiology · 160d
Cleared Feb 24, 2025
ExamVue Apex
K244010 · MQB
Jpi Healthcare Co, Ltd.
Radiology · 60d
Cleared Feb 24, 2025
OncoStudio (OS-01)
K242994 · QKB
Oncosoft. Co., Ltd.
Radiology · 151d
Cleared Feb 21, 2025
Sonio Suspect
K243614 · POK
Sonio
Radiology · 91d