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
2137–2160 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Sep 29, 2021
ImmersiveTouch
K210726 · LLZ
Immersivetouch, Inc.
Radiology · 202d
Cleared Sep 28, 2021
SubtlePET
K211964 · KPS
Subtle Medical, Inc.
Radiology · 96d
Cleared Sep 28, 2021
Panther OIS
K211760 · IYE
Prowess, Inc.
Radiology · 112d
Cleared Sep 28, 2021
EzDent Web
K211700 · LLZ
Ewoosoft Co., Ltd.
Radiology · 117d
Cleared Sep 28, 2021
SIDDHARTH-II
K210894 · IYE
Panacea Medical Technologies Pvt. , Ltd.
Radiology · 187d
Cleared Sep 27, 2021
Imaging Plate Scanner, i-Scan
K212080 · MUH
Guilin Woodpecker Medical Instrument...
Radiology · 87d
Cleared Sep 24, 2021
Collaboration Live
K212777 · LLZ
Philips Ultrasound, Inc.
Radiology · 23d