FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
1153–1176 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 15, 2024
InVision™ 1.5 Surgical Theatre
K240157 · LNH
Deerfield Imaging, Inc.
Radiology · 27d
Cleared Feb 15, 2024
Medical Monitor (21HQ613D)
K240130 · PGY
Lg Electronics.Inc
Radiology · 29d
Cleared Feb 15, 2024
Contour Shoulder
K233656 · MOS
Quality Electrodynamics
Radiology · 93d
Cleared Feb 15, 2024
MS55 Plus Digital Color Doppler Ultrasound System (MS55)
K231659 · IYN
Medisono
Radiology · 253d
Cleared Feb 14, 2024
Radiography 7000 M
K233678 · IZL
Philips Medical Systems Dmc GmbH
Radiology · 90d
Cleared Feb 13, 2024
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic...
K233788 · IYN
Philips Ultrasound, LLC
Radiology · 77d
Cleared Feb 13, 2024
EXPD 4343S
K232082 · MQB
DRTECH Corporation
Radiology · 215d
Cleared Feb 13, 2024
QOCA® image Smart RT Contouring System
K231855 · QKB
Quanta Computer, Inc.
Radiology · 235d
Cleared Feb 12, 2024
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)
K233401 · IYO
Eieling Technology Limited
Radiology · 131d
Cleared Feb 12, 2024
Mimics Cardiac Planner
K233217 · LLZ
Materialise NV
Radiology · 137d
Cleared Feb 08, 2024
XVbeam2000
K233914 · EHD
Shenzhen Xpectvision Technology Co.,...
Radiology · 58d
Cleared Feb 08, 2024
HealthFLD
K233080 · JAK
Nano-X AI , Ltd.
Radiology · 135d
Cleared Feb 08, 2024
Leksell GammaPlan (LGP)
K232854 · IWB
Elekta Solutions AB
Radiology · 146d
Cleared Feb 08, 2024
neuro42 MRI System
K232644 · LNH
Neuro42, Inc.
Radiology · 162d
Cleared Feb 08, 2024
Aid-U
K231662 · LLZ
Iaid
Radiology · 246d
Cleared Feb 06, 2024
5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP,...
K233897 · PGY
Shenzhen Beacon Display Technology...
Radiology · 57d
Cleared Feb 05, 2024
Ziehm Vision RFD
K240099 · OWB
Ziehm Imaging GmbH
Radiology · 24d
Cleared Feb 05, 2024
Smart Fit Knee 3.0T
K233600 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 88d
Cleared Feb 05, 2024
Viz HDS, Viz Volume Plus, Viz ICH+
K232363 · QIH
Viz. Ai, Inc.
Radiology · 182d
Cleared Feb 01, 2024
Kelowna GYN and Crook Prostate Templates
K232949 · JAQ
Varian Medical Systems, Inc.
Radiology · 134d
Cleared Feb 01, 2024
Augmented Reality Application
K232339 · LLZ
Sira Medical, Inc.
Radiology · 181d
Cleared Feb 01, 2024
CAAS MR Solutions
K232007 · LLZ
Pie Medical Imaging BV
Radiology · 210d
Cleared Jan 31, 2024
CEPHX- Cephalometric Analysis Software
K231396 · LLZ
Orca Dental AI , Ltd.
Radiology · 261d
Cleared Jan 30, 2024
Ziehm Vision FD
K240020 · OWB
Ziehm Imaging GmbH
Radiology · 28d