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 ×
15,695 results
2233–2256 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 02, 2021
TaiChiB
K210921 · IYE
Our United Corporation
Radiology · 218d
Cleared Oct 29, 2021
ds Head 32ch 3.0T
K213351 · MOS
Invivo Corporation (Business Trade...
Radiology · 21d
Cleared Oct 29, 2021
ATEC Alignment App
K211987 · LLZ
Alphatec Spine, Inc.
Radiology · 123d
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