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
337–360 of 15,570
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 24, 2025
a2z-Unified-Triage
K252366 · QAS
A2z Radiology Ai, Inc.
Radiology · 117d
Cleared Nov 24, 2025
Voluson Expert 18
K252328 · IYN
GE Medical Systems Ultrasound and...
Radiology · 122d
Cleared Nov 21, 2025
Archy Dental Imaging
K251880 · LLZ
Archy Dental, Inc.
Radiology · 156d
Cleared Nov 20, 2025
syngo.MR Applications (VB80)
K253495 · LLZ
Siemens Healthineers AG
Radiology · 23d
Cleared Nov 20, 2025
MAGNETOM Free.Max
K251822 · LNH
Siemens Shenzhen Magnetic Resonance ,...
Radiology · 160d
Cleared Nov 20, 2025
PlanOne 1
K250963 · MUJ
Cosylab Jsc, Control System Laboratory
Radiology · 234d
Cleared Nov 19, 2025
Guided Aarhus Applicator Set
K252884 · JAQ
Varian Medical Systems
Radiology · 70d
Cleared Nov 17, 2025
ACUSON Maple Diagnostic Ultrasound System
K253487 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Nov 17, 2025
DTX Studio Assist
K252086 · MYN
Nobel Biocare C/O Medicim NV
Radiology · 138d
Cleared Nov 14, 2025
AutoDensity
K251078 · QIH
Eos Imaging
Radiology · 220d
Cleared Nov 14, 2025
Second Opinion® Panoramic
K250525 · MYN
Pearl, Inc.
Radiology · 266d
Cleared Nov 13, 2025
ACUSON Juniper Diagnostic Ultrasound System
K253457 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 38d
Cleared Nov 13, 2025
Dental Computed Tomography X-ray System
K251842 · OAS
Fussen Technology Co., Ltd.
Radiology · 150d
Cleared Nov 12, 2025
PeekMed web
K252452 · QIH
Peek Health, S.A.
Radiology · 100d
Cleared Nov 10, 2025
EzSensor HD, EzSensor UHD
K252570 · MUH
Qpix Solutions, Inc.
Radiology · 88d
Cleared Nov 07, 2025
Fibresolve (with PCCP)
K252041 · QWO
Imvaria, Inc.
Radiology · 130d
Cleared Nov 07, 2025
Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER,...
K251853 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 143d
Cleared Nov 07, 2025
SugarBug (1.x)
K250264 · MYN
Bench7, Inc.
Radiology · 282d
Cleared Nov 06, 2025
BriefCase-Triage
K253265 · QAS
Aidoc Medical , Ltd.
Radiology · 38d
Cleared Nov 06, 2025
Adaptix Ortho350
K252133 · IZF
Adaptix Limited
Radiology · 122d
Cleared Nov 06, 2025
Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
K251004 · OXO
Hefei Chimed Intelligent Machine Co.,...
Radiology · 219d
Cleared Nov 04, 2025
VXvue
K251410 · LLZ
Vieworks Co., Ltd.
Radiology · 181d
Cleared Nov 04, 2025
Cios Select
K250241 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 281d
Cleared Nov 03, 2025
Sonosite MT Ultrasound System
K253448 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 32d