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
457–480 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 22, 2025
PROMO
K251443 · IZL
DRGEM Corporation
Radiology · 105d
Cleared Aug 22, 2025
Diagnostic Ultrasound System (MX7)
K251192 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 127d
Cleared Aug 22, 2025
MammoScreen BD
K243685 · QIH
Therapixel
Radiology · 266d
Cleared Aug 21, 2025
Vista OS, Vista AI Scan, RTHawk
K251029 · LNH
Vista AI, Inc.
Radiology · 141d
Cleared Aug 20, 2025
Salix Coronary Plaque (V1.0.0)
K251837 · QIH
Artrya Limited
Radiology · 65d
Cleared Aug 20, 2025
Methinks CTA Stroke
K251590 · QAS
Methinks Software, S.L
Radiology · 89d
Cleared Aug 20, 2025
ACUSON Sequoia Diagnostic Ultrasound System
K251481 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 99d
Cleared Aug 15, 2025
VEA Align
K251747 · QIH
Eos Imaging
Radiology · 70d
Cleared Aug 15, 2025
PHAROS
K250170 · KPS
Brightonix Imaging
Radiology · 206d
Cleared Aug 12, 2025
DS Core Diagnosis
K250755 · QIH
Dentsply Sirona, Inc.
Radiology · 153d
Cleared Aug 11, 2025
Saige-Dx
K251873 · QDQ
DeepHealth, Inc.
Radiology · 54d
Cleared Aug 11, 2025
RW-1
K232456 · LLZ
Mediott, Inc.
Radiology · 728d
Cleared Aug 07, 2025
UNiD™ Spine Analyzer
K251629 · QIH
Medicrea International S.A.S....
Radiology · 71d
Cleared Aug 07, 2025
Navigo Workstation 2.3 (FPRMC00039)
K250664 · LLZ
UC-CARE , Ltd.
Radiology · 155d
Cleared Aug 06, 2025
InVision™ 3T Recharge Operating Suite
K252239 · LNH
Imris Imaging, Inc.
Radiology · 20d
Cleared Aug 06, 2025
Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
K251038 · LLZ
Shen Zhen Cambridge-Hit Co., Ltd.
Radiology · 125d
Cleared Aug 05, 2025
uMR Jupiter
K250246 · LNH
Shanghai United Imaging Healthcare...
Radiology · 190d
Cleared Aug 05, 2025
iPETcertum (v1.0)
K244016 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 221d
Cleared Aug 04, 2025
HnX-P1, HnX-PB
K251223 · IZL
H&abyz Co., Ltd.
Radiology · 105d
Cleared Aug 01, 2025
Revolution Vibe
K250941 · JAK
Ge Medical Systems, LLC
Radiology · 126d
Cleared Aug 01, 2025
INNOVISION-DXII
K250790 · KPR
Dk Medical Systems Co., Ltd.
Radiology · 140d
Cleared Aug 01, 2025
Deepsight NeedleVue LC1 Ultrasound System
K250381 · IYO
DeepSight Technology, Inc.
Radiology · 171d
Cleared Jul 31, 2025
Biograph Trinion
K251561 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 71d
Cleared Jul 31, 2025
YSIO X.pree
K250738 · KPR
Siemens Medical Solutions
Radiology · 142d