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
121–144 of 15,570
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 15, 2026
uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE...
K253716 · IYN
Wuhan United Imaging Healthcare Co.,Ltd
Radiology · 172d
Cleared May 15, 2026
Neurophet SCALE PET
K252563 · QIH
Neurophet., Inc.
Radiology · 274d
Cleared May 14, 2026
BriefCase-Triage
K261317 · QAS
Aidoc Medical , Ltd.
Radiology · 23d
Cleared May 14, 2026
Palmtop Ultrasound Diagnostic System (MT10P/MT10)
K260111 · IYN
Mytech Intelligence (Shenzhen) Co., Ltd.
Radiology · 120d
Cleared May 14, 2026
RAYMO Mobile X-ray System (Model: RAYMO)
K260085 · IZL
DRGEM Corporation
Radiology · 122d
Cleared May 14, 2026
SubtleHD-PET (1.x)
K254013 · LLZ
Subtle Medical, Inc.
Radiology · 150d
Cleared May 14, 2026
ART.1-US
K253078 · MUJ
Seetreat Pty, Ltd.
Radiology · 233d
Cleared May 13, 2026
Morph
K260032 · QIH
BeauBrain Healthcare, Inc.
Radiology · 127d
Cleared May 12, 2026
Rayvolve
K260378 · QBS
AZmed
Radiology · 96d
Cleared May 11, 2026
Diagnostic Ultrasound System (MU9)
K260846 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 56d
Cleared May 11, 2026
Velmeni for Dentists (V4D) Endo-Perio
K252953 · MYN
Velmeni, Inc.
Radiology · 237d
Cleared May 08, 2026
AerFrame Patient Immobilization System (AFPIS)
K260792 · IYE
Stabilix, LLC
Radiology · 58d
Cleared May 08, 2026
HipGuide (V 1.0.0.0)
K260321 · LLZ
Orthopedic Driven Imaging, LLC
Radiology · 98d
Cleared May 05, 2026
Healium Intelliscan LX192LC
K261132 · IYN
Healium Intelliscan Corporation
Radiology · 29d
Cleared May 05, 2026
Lumify Diagnostic Ultrasound System
K252558 · IYN
Philips Ultrasound, LLC
Radiology · 265d
Cleared May 04, 2026
Neowise
K260716 · LLZ
Cefla S.C.
Radiology · 60d
Cleared May 04, 2026
MammoSightAI
K252954 · QFM
Neurocareai, Inc. (Dba Savelife.Ai)
Radiology · 230d
Cleared Apr 30, 2026
Synapse 3D Base Tools (V7.2)
K254189 · QIH
Fujifilm Corporation
Radiology · 128d
Cleared Apr 30, 2026
Intelligent NR
K252503 · OWB
Canon, Inc.
Radiology · 265d
Cleared Apr 29, 2026
ES-Series
K260589 · IYN
E-Scopics
Radiology · 68d
Cleared Apr 29, 2026
syngo Application Software
K254184 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 127d
Cleared Apr 29, 2026
DeepHealth ProstateAI
K253682 · QDQ
Quantib B.V.
Radiology · 159d
Cleared Apr 24, 2026
LungPoint Virtual Bronchoscopic Navigation (VBN) Software
K260009 · LLZ
Broncus Medical, Inc.
Radiology · 112d
Cleared Apr 24, 2026
ARTIS icono floor
K254173 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 122d