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
2257–2280 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 22, 2021
syngo.CT Skull Unfolding
K203411 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 245d
Cleared Jul 20, 2021
ACUSON Sequoia Diagnostic Ultrasound System
K211859 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Jul 20, 2021
Change Healthcare Anatomical AI
K210719 · QIH
Change Healthcare Canada Company
Radiology · 132d
Cleared Jul 20, 2021
Chest-CAD
K210666 · MYN
Imagen Technologies, Inc.
Radiology · 137d
Cleared Jul 20, 2021
ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL...
K203765 · LLZ
Zirkonzahn Srl
Radiology · 209d
Cleared Jul 14, 2021
SMART FINDER
K203509 · IZH
Ims Giotto S.P.A.
Radiology · 226d
Cleared Jul 12, 2021
PowerLook Density Assessment V4.0
K211506 · QIH
Icad, Inc.
Radiology · 59d
Cleared Jul 12, 2021
RadiForce RX370
K211491 · PGY
Eizo Corporation
Radiology · 60d
Cleared Jul 09, 2021
PRIMO S
K211542 · MQB
A.T.S. Applicazione Tecnologie...
Radiology · 51d
Cleared Jul 09, 2021
HM70 EVO Diagnostic Ultrasound System
K210713 · IYN
Samsung Medison Co., Ltd.
Radiology · 121d
Cleared Jul 08, 2021
HALO
K211788 · QAS
Nicolab B.V.
Radiology · 29d
Cleared Jul 08, 2021
NubeX
K211480 · LLZ
Techheim Co., Ltd.
Radiology · 57d
Cleared Jul 08, 2021
iSR'obot Mona Lisa 1.0
K203659 · IYO
Biobot Surgical Pte., Ltd.
Radiology · 205d
Cleared Jul 08, 2021
PRE-SURE
K201835 · LLZ
Lazarus 3D, Inc.
Radiology · 371d
Cleared Jul 07, 2021
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K211818 · LNH
Hyperfine, Inc.
Radiology · 26d
Cleared Jul 07, 2021
ONE Planner Hip
K210653 · LLZ
Orthosoft D/B/A Zimmer Cas
Radiology · 125d
Cleared Jul 01, 2021
ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9
K211782 · OWB
Controlrad, Inc.
Radiology · 22d
Cleared Jul 01, 2021
decimal Bolus
K211511 · MUJ
.Decimal, LLC
Radiology · 48d
Cleared Jul 01, 2021
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
K211337 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 59d
Cleared Jul 01, 2021
MAGNETOM Free.Max
K210611 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 122d
Cleared Jun 29, 2021
STAGE
K210843 · LNH
Spintech, Inc.
Radiology · 99d
Cleared Jun 29, 2021
RayStation 10.1
K210645 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 118d
Cleared Jun 29, 2021
12MP Color Digital Mammography LCD Monitor CL-S1200
K203733 · PGY
Jvckenwood Corporation
Radiology · 190d
Cleared Jun 29, 2021
Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20,...
K203645 · IYN
Supersonic Imagine
Radiology · 197d