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
2161–2184 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 29, 2021
Critical Care Suite with Endotracheal Tube Positing AI algorithm
K211161 · QIH
Ge Medical Systems, LLC
Radiology · 193d
Cleared Oct 29, 2021
nView s1 with nav option
K211064 · OWB
Nview Medical
Radiology · 203d
Cleared Oct 26, 2021
CLISIS SYSTEMS, Discovery RF180
K213081 · IZF
General Medical Merate S.P.A
Radiology · 33d
Cleared Oct 25, 2021
Advanced Algorithms for Treatment Management Applications (AATMA)
K212218 · QKB
Elekta Solutions AB
Radiology · 101d
Cleared Oct 22, 2021
FlightPlan for Liver
K210807 · LLZ
GE Medical Systems SCS
Radiology · 219d
Cleared Oct 21, 2021
Orthoscan Tau Mini C-Arm
K213113 · OXO
Orthoscan, Inc.
Radiology · 24d
Cleared Oct 20, 2021
iRAD
K212470 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 75d
Cleared Oct 20, 2021
Contour ProtegeAI
K210632 · QKB
Mim Software, Inc.
Radiology · 231d
Cleared Oct 19, 2021
DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
K212254 · OAS
Hdx Will Corp.
Radiology · 92d
Cleared Oct 18, 2021
0909FCB, 1212FCA
K212753 · MQB
Rayence Co., Ltd.
Radiology · 48d
Cleared Oct 18, 2021
Change Healthcare Cardiology
K212528 · LLZ
Change Healthcare Israel , Ltd.
Radiology · 68d
Cleared Oct 14, 2021
StrokeSENS LVO
K212261 · QAS
Circle Neurovascular Imaging, Inc.
Radiology · 86d
Cleared Oct 14, 2021
SwiftMR
K210999 · LLZ
Airs Medical, Inc.
Radiology · 195d
Cleared Oct 14, 2021
Brainance MD
K202808 · LLZ
Advantis Medical Imaging Single...
Radiology · 386d
Cleared Oct 12, 2021
VBrain-OAR
K212116 · QKB
Vysioneer, Inc.
Radiology · 97d
Cleared Oct 07, 2021
Digital Intraoral X-ray Imaging System
K212279 · MUH
Iray Technology Taicang , Ltd.
Radiology · 79d
Cleared Oct 07, 2021
OASIS MRI System
K211406 · LNH
Hitachi Healthcare Americas
Radiology · 154d
Cleared Oct 05, 2021
RTHawk, HeartVista Cardiac Package
K212233 · LNH
Heartvista, Inc.
Radiology · 81d
Cleared Oct 05, 2021
NAVIPLAN - CT Planning Software for Total Hip Replacement
K211429 · LLZ
Naviswiss AG
Radiology · 151d
Cleared Oct 04, 2021
EzDent-i/ E2/ Prora View/ Smart M Viewer
K211795 · LLZ
Ewoosoft Co., Ltd.
Radiology · 116d
Cleared Oct 01, 2021
Zenition 70
K212813 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 28d
Cleared Oct 01, 2021
Elekta Unity
K212114 · IYE
Elekta Solutions AB
Radiology · 86d
Cleared Sep 30, 2021
Accuray Precision Treatment Planning System
K212794 · IYE
Accuray Incorporated
Radiology · 28d
Cleared Sep 30, 2021
NAEOTOM Alpha, Scan&GO
K211591 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 129d