Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Radiology × Cleared only ×
15,676 results
2233–2256 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Sep 24, 2021
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic...
K212704 · IYN
Philips Medical Systems
Radiology · 29d