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
1753–1776 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 06, 2022
R2 Studio Q/RCT820
K222219 · OAS
Megagen Implant Co., Ltd.
Radiology · 134d
Cleared Dec 05, 2022
BriefCase
K222692 · QFM
Aidoc Medical , Ltd.
Radiology · 90d
Cleared Dec 05, 2022
ClearRead CT
K221612 · OEB
Riverain Technologies, Inc.
Radiology · 185d
Cleared Dec 02, 2022
CardioGraphe
K213465 · JAK
Arineta , Ltd.
Radiology · 400d
Cleared Dec 01, 2022
ProBeam 360° Proton Therapy System
K221791 · LHN
Varian Medical Systems, Inc.
Radiology · 163d
Cleared Dec 01, 2022
Bolt Navigation System
K213768 · OWB
Circinus Medical Technology, LLC
Radiology · 365d
Cleared Nov 28, 2022
TorchTM Software
K220630 · LLZ
Voximetry, Incorporated
Radiology · 269d
Cleared Nov 27, 2022
Wireless/Wired X-Ray Flat Panel Detectors
K223009 · MQB
Allengers Medical Systems Limited
Radiology · 59d
Cleared Nov 25, 2022
VSI HoloMedicine
K213215 · LLZ
Apoqlar GmbH
Radiology · 422d
Cleared Nov 23, 2022
Ai Ray Dental X-Ray Device
K222569 · EHD
Guilin Woodpecker Medical Instrument...
Radiology · 91d
Cleared Nov 22, 2022
Vision 2, EVARVision, TrackVision 2, HeartVision 2
K223152 · LLZ
GE Medical Systems SCS
Radiology · 47d
Cleared Nov 22, 2022
DynamicIQ
K222895 · KPS
GE Medical Systems SCS
Radiology · 60d
Cleared Nov 22, 2022
Denti.AI Auto-Chart
K222054 · LLZ
Denti.Ai Technology, Inc.
Radiology · 133d
Cleared Nov 22, 2022
VitroPRO
K222052 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 133d
Cleared Nov 22, 2022
CINA
K221716 · QAS
Avicenna.Ai
Radiology · 162d
Cleared Nov 22, 2022
Avenda Health AI Prostate Cancer Planning Software
K221624 · POK
Avenda Health, Inc.
Radiology · 169d
Cleared Nov 22, 2022
Minimally Invasive Prostate Surgery Navigation System
K221499 · LLZ
Augment Intelligent Medical System...
Radiology · 183d
Cleared Nov 22, 2022
AccuCTP
K220663 · LLZ
ArteryFlow Technology Co., Ltd.
Radiology · 260d
Cleared Nov 21, 2022
SIS System (Version 5.6.0)
K223032 · QIH
Surgical Information Sciences, Inc.
Radiology · 53d
Cleared Nov 21, 2022
SM-V
K222951 · IZL
Sedecal., Sa.
Radiology · 55d
Cleared Nov 18, 2022
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
K223124 · MQB
DRTECH Corporation
Radiology · 46d
Cleared Nov 18, 2022
BriefCase
K221330 · QAS
Aidoc Medical , Ltd.
Radiology · 196d
Cleared Nov 17, 2022
SKR 3000
K223267 · MQB
Konica Minolta, Inc.
Radiology · 24d
Cleared Nov 17, 2022
OmegaAI Image Viewer
K222476 · LLZ
Ramsoft, Inc.
Radiology · 93d