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
145–168 of 15,570
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 24, 2026
EdgeFlow Gel Pad
K252337 · MUI
Edgecare, Inc.
Radiology · 270d
Cleared Apr 23, 2026
0.55T 12Ch Breast Coil
K260947 · MOS
Neocoil, LLC
Radiology · 31d
Cleared Apr 23, 2026
DS Core CBCT Anatomy
K260785 · QIH
Dentsply Sirona
Radiology · 44d
Cleared Apr 23, 2026
Lunit INSIGHT MMG (v1.1.10)
K260320 · QDQ
Lunit, Inc.
Radiology · 83d
Cleared Apr 23, 2026
CCI PACS VIEWER (PACS-US-001)
K254237 · LLZ
CliniComp, Intl.
Radiology · 115d
Cleared Apr 23, 2026
ARTIS genio floor
K253752 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 149d
Cleared Apr 23, 2026
ProBeam 360 Proton Therapy System v3.0
K252815 · LHN
Varian Medical Systems, Inc.
Radiology · 231d
Cleared Apr 22, 2026
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
K253163 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 208d
Cleared Apr 22, 2026
uOmnispace.MR
K253077 · QIH
Shanghai United Imaging Healthcare...
Radiology · 211d
Cleared Apr 20, 2026
Lunar Astra
K252718 · KGI
GE Medical Systems Ultrasound &...
Radiology · 235d
Cleared Apr 20, 2026
Folliscan
K252332 · QIH
Mim Fertility
Radiology · 269d
Cleared Apr 17, 2026
EdgeFlow UW20
K252237 · IYO
Edgecare, Inc.
Radiology · 274d
Cleared Apr 15, 2026
VERIQA RT EPID 3D
K252258 · IYE
Ptw-Freiburg...
Radiology · 268d
Cleared Apr 14, 2026
Critical Care Suite with Enteric Tube Positioning AI Algorithm
K253502 · QIH
Ge Medical Systems, LLC
Radiology · 166d
Cleared Apr 14, 2026
HD 8Ch Wrist Array
K252587 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 242d
Cleared Apr 10, 2026
Overjet Iris Intelligent Imaging System
K253930 · QIH
Overjet, Inc.
Radiology · 122d
Cleared Apr 10, 2026
syngo Dynamics (VA41F)
K253689 · QIH
Siemens Healthcare GmbH
Radiology · 140d
Cleared Apr 10, 2026
AeroDR TX c02
K253446 · KPR
Dk Medical Systems Co., Ltd.
Radiology · 190d
Cleared Apr 10, 2026
AI-Rad Companion Organs RT
K252548 · QKB
Siemens Healthcare GmbH
Radiology · 240d
Cleared Apr 10, 2026
DeepBT Detector-Plus
K252190 · QKB
Aitewan Biomedical Technology, Inc.
Radiology · 270d
Cleared Apr 09, 2026
RCT800
K260462 · OAS
Ray Co., Ltd.
Radiology · 56d
Cleared Apr 09, 2026
Accuro XV
K254021 · IYO
Rivanna Medical, Inc.
Radiology · 114d
Cleared Apr 06, 2026
APERTO Lucent MRI System
K253862 · LNH
Fujifilm Corporation
Radiology · 124d
Cleared Apr 06, 2026
6450 Ultrasound System (MyLabE80)
K253288 · IYN
Esaote, S.P.A.
Radiology · 189d