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
265–288 of 15,570
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 22, 2026
AV Vascular
K253735 · QIH
Philips Medical Systems Nederland B.V.
Radiology · 59d
Cleared Jan 22, 2026
AI-Rad Companion Brain MR
K253057 · QIH
Siemens Healthcare GmbH
Radiology · 122d
Cleared Jan 21, 2026
Halcyon, Ethos Radiotherapy System (5.0)
K252977 · IYE
Varian Medical Systems, Inc.
Radiology · 126d
Cleared Jan 20, 2026
Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
K253597 · IYN
Canon Medical Systems Corporation
Radiology · 63d
Cleared Jan 20, 2026
uCT 780 with uWS-CT-Dual Energy Analysis
K253173 · JAK
Shanghai United Imaging Healthcare...
Radiology · 116d
Cleared Jan 20, 2026
DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35...
K250954 · KPR
Carestream Health
Radiology · 298d
Cleared Jan 16, 2026
Azurion R3.1
K254186 · OWB
Philips Medical Systems B.V.
Radiology · 24d
Cleared Jan 16, 2026
Imagine® Enterprise Suite
K252634 · QIH
Softlink International Private Limited
Radiology · 149d
Cleared Jan 16, 2026
qXR-Detect
K251934 · MYN
Qure.Ai Technologies
Radiology · 206d
Cleared Jan 15, 2026
BIOGRAPH One
K253023 · OUO
Siemens Healthineers AG
Radiology · 118d
Cleared Jan 15, 2026
Diagnocat
K252934 · MYN
DGNCT, LLC
Radiology · 122d
Cleared Jan 15, 2026
EMLA (Elekta Evo)
K252188 · IYE
Elekta Solutions AB
Radiology · 185d
Cleared Jan 14, 2026
dS Base 1.5T
K254190 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 22d
Cleared Jan 14, 2026
ExacTrac Dynamic (2.0.2)
K254010 · IYE
Brainlab SE
Radiology · 30d
Cleared Jan 14, 2026
Orthoscan TAU MVP Mini C-Arm System
K252579 · OXO
Ziehm-Orthoscan, Inc.
Radiology · 152d
Cleared Jan 13, 2026
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)
K254001 · KPS
Spectrum Dynamics Medical, Ltd.
Radiology · 29d
Cleared Jan 08, 2026
3DICOM MD Cloud
K253784 · LLZ
Singular Health Pty, Ltd.
Radiology · 43d
Cleared Jan 08, 2026
View
K253639 · LLZ
Ge Healthcare
Radiology · 50d
Cleared Jan 08, 2026
LOGIQ Totus
K253370 · IYN
GE Medical Systems Ultrasound and...
Radiology · 100d
Cleared Jan 07, 2026
LOGIQ Fortis
K253366 · IYN
GE Medical Systems Ultrasound and...
Radiology · 99d
Cleared Jan 07, 2026
DS Core Detect
K253009 · MYN
Dentsply Sirona, Inc.
Radiology · 110d
Cleared Jan 07, 2026
BriefCase-Triage: CARE Multi-triage CT Body
K252970 · QAS
Aidoc Medical , Ltd.
Radiology · 112d
Cleared Jan 05, 2026
maiLink
K253008 · LLZ
Maihub Corp.
Radiology · 108d
Cleared Jan 05, 2026
ChartCheck (RADCH V1.6)
K252988 · IYE
Radformation, Inc.
Radiology · 109d